SAH@MCA P experiencing VERTIGO while performing YOGA poses - required 4 diagnosed DDD.
P bill IDs Sugita CLIP installed. There are 99 + types. EACH has specific Tesla induction reactivity.
P has undergone MRI, MRA procedures - since the insert12-18-2012.
If the clip has NOT corroded - in an oxygen saturated AND moist environment - near P MCA - It MAY be safe - at no GTR TESLA - than P did previous. FDA ref P - to THE FOI ACT.
P IS STILL WAITING for HOSP. Response - to failure to follow FDA MED. Device onstructions. P did file FOI Req. FDA standing by
Subject Read: [Internet] I am NOT contacting Mission Health System - today - with a "complaint" - of any kind. Rather, I am seeking information - AND IT IS urgent
From Mission ROI MGMT
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Subject Read: [Internet] I am NOT contacting Mission Health System - today - with a "complaint" - of any kind. Rather, I am seeking information - AND IT IS urgent
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Message 38 of 865
Subject Read: [Internet] Mission Hospital patient Susan Neuhart - completed patient Information Request FORMS
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no-reply@mizuho.com
Subject To obtain information related to the aneurysm clip
From no-reply
To SusanREDACT
Date 2021-07-27 19:04
Dear Ms. Neuhart,
Thank you for your communication.
Please do contact the hospital where the surgery did take place, in order to replace the ‘patient card’.
- Kind regards,
Mizuho America, Inc.
‘DO NOT REPLY’ – This mailbox is not monitored. If you would like to contact us please reach out to us at www.mizuho.com
Subject Clip info
From hans eig.net
To susanREDACT
Date 2021-07-27 07:23
Dear (Susan's Medical Doctors) [ Goldstick, Sadikov ]
[ also previous Victor Perry MD NeuroSurgeon - 2012, Duff A. Rardin MD 2013, Xiasong Zhao 2015 ]
I am making progress in obtaining the information required
- so that you can advise me on the needed medical steps to take - related to recent VERTIGO.
In fact, yesterday [7-25-2021] it came to my attention [that] Mizuho Medical did - at some point - anticipate the need for the very information WE are seeking today. In fact, they formalized and included this "anticipation" product - into their product brochure ( as page 7 ). I have copied the product brochure [all 12 pages ] and recorded page 7 in detail :
( https://hansandcassady.org/MIZUHO-end-user-CLIP-BROCHURE-PAGE-7.html ).
It is coincidence (certainly) - but may be more - [that] - a "white lady" [me] had - the kind of "stroke" - that is much more prevalent - in African Americans.
Consider: 1) - I was born in 1954 (disabled with pectus carinatum) - which I overcame fully - at puberty. My father (Milo G. CassAdy) - a Scotsman - loved John Kennedy. Thus, I am aware of the history of Bobby Kennedy - telling his brother (US President John Kennedy ) "John, there are laws against what they are doing in the South - it's just that - no one is enforcing the laws!" And, John said: "Bobby - what do you need? Do it! We are going to enforce the laws! [ https://www.pbs.org/wgbh/americanexperience/features/kennedys-and-civil-rights/ ... ]
2) - I survived my stroke event. Many Americans survive "stroke" events; But, it is statistlically unusual - for humans to survive an SAH@MCA stroke event - without some form of permanent disability. [ cite ] As Hans & I have tried to make clear - for all of my life (that I can remember) - I have been afflicted with "bull-headedness". It is not easy for me - to accept "no!"; And, because of my "Scottish" heritage [CassAdy] - it may not be possible. AND, I have been blessed - to have been surrounded - by people - who have prevented - this condition - of "bull-headedness" - being fatal (to me). In fact, growing up WHERE and WHEN I did - also provided me with GREAT examples - to follow. One example: Dr. Martin Luther King Jr. - was more (to me) - than just a "personality" - on TV. His presence was also a part of my life - as I attended "inner-city" Columbus, Ohio Public Schools (1960 - 1972). Thus, I know [ I saw] "pushing" ["bull-headedness"] and being "civil" - can make a difference - with people and COMPUTERS. Dr. King taught us "non-violence". Working with "computers" - teaches a "user" (and "programmer" - such as I was) - to satisfy the "compiler". This is an internal unit of each computer - that interprets the SYNTAX and "logic" - of each coded instruction. If the submitted instructions are not perfectly correct - the data programmer will be alerted - with an ERROR! message. Thus, you may "give up" - or, try to fix the SYNTAX. At which point - if successful - the programmer's latest effort - will be met with more "internal logic units" - to determine if the code submitted can be processed - to a successful conclusion - and - perhaps a "correct" answer. OR, the computer may enter a "continuous loop" cycle - of processing; which, ALL OF THESE SCENARIOS - did happen to me. But - because of Dr. King's example - AND, other factors - I DID NOT GIVE UP.
3) - I was permitted (by US Government programs) to attend a public university (UWGB) - where "females" - were encouraged to enroll in typically - historically - "male" classes (CIRCA 1977). I selected a new cirriculum - related to being an "EPA" agent. UWGB permitted me - to complement the "core" courses required - and, I had a GREAT TIME! As can be seen, on my transcript - I liked computers - AND (they) liked me. My teachers [ Professors Alice Goldsby Biology & Nancy Sell Physics ] helped to found the Women In Science program. Their efforts preceded the Dartmouth program - and, they prevented people from "holding me back" - because I was "different" - kind of girl. Indeed, in a predominantly "Catholic" atmosphere (Brown County Wisconsin) - I gave "physical custody" - of my young daughter to her biological father - because this made "practical sense" - to a Scottish & German girl. He had a 'college degree' [from Ohio State University] - and, I had helped him to earn his MBA - before our divorce. This decision (giving him physical" custody) is what enabled me to earn so many "As" - in my classes. Unfettered - by day-to-day "childcare responsibilities" - and, the constant need - to request "more money" - from the child's employed father - I not only "took the required classes" - I was able to also "work" - with computers - and, apply what I was learning. Indeed, the NCR Corporation hired me (1982) - in part - because - I had designed, coded and implemented - the School's Automated Weather Station System - on VAX-VMS computers - housed at the school's (then) new Computer building. I laid the System's End User Manual [that I had written' - on the "interview conference table" - and, NCR executives said "YES!" In fact, I was a perfect fit for the Software Engineering Technical Writing job opening. ... I documented the Mid Range Local Area Network ( the Mid-Atlantic cable architecture - for European data exchange) - and, packet switched networks - which are the basis of the internet. General Electric hired me - because I was a female - AND, married to the talented fellow (they wanted) - to help them perfect the "Out the window view" - pilots flying American Fighter Jets would see - if they hit the target. GE made flight simulators - AND, weapons systems - for the DDG51 war-ship ( which, I documented "HOW" - they were suppose to be used ) - ... until, I got into an argument - with my boss - who had been a "Major" - in the "military". I told him - to "kiss my ass" - and, went to work for Battelle Research - in Columbus, Ohio - where my 15 year old daughter was. I hired her to "work for me" - when - she was 16 - and, gave her a "sign-ON" bonus - of a NEW Toyota Celica.
4) - So, I know about "end user manuals" - and, I ALSO know - there is [PROBABLY] a reason it is not spelled out - in Mizuho's manual : ... "RESPONSIBILITY" [WHO'S RESPONSIBILITY IS IT? ].
So, it is with this NATURALLY "bullheaded" predisposition (because I am genetically Scottish & German )
- AND experience [born] of developing Software End User Manuals; - YET, knowing that laws don't enforce themselves - THAT - I arrive to the "task" at hand:
WHICH IS - Finding out - exactly - WHO dropped the ball?
I have faith this will be "born out" eventually ( MLK ) ...
1. Mizuho Medical anticipated this level of "detailed knowledge" - about the "medical device" inserted into human brains would be necessary; [ ref. 1 ]
Thus, they manufacture a "patient card" - as a "featured" product - and, highlight the feature - in their product brochure. [ ref. 2 ]
2. Hospital "purchasing agents" have many "Neurosurgery" systems providers - to choose from. [ ref. 3 ]
3. American licensed Neurosurgeons (MDs) - have the option to use the "aneurysm clips" - they prefer.
4. All "medical device", "aneurysm clips" - used in the United States - MUST be approved by the US-FDA. [ref. 4 ]
5. Mizuho Medical "aneurysm clips" - are approved for use in the United States - by the US-FDA. [ ref. 5 ]
6. And, Susan Neuhart - although billed - for a "Sugita Aneurysm Clip" [ CLIP 11.5 T2 STR 12 MM 1 1700110 Sugita BRAIN] [ ref. 6 ]
- was never given a Mizuho Medical "aneurysm clip" "patient card" . [ ref. 7 ]
7. Although her "care givers" ( members of Mission Health System : surgery billing image ) .... may have been.
8. We begin with the hospital - where the emergency surgery was performed - AND, Ms. Neuhart was held - in "intensive care" level facilities - for 30+ days.
9. During this time, Ms. Neuhart was "imaged" and "CAT-scanned" - as necessary. That is, at least one time - perhaps more.
10. After her release - from the hospital - Mr. Neuhart - has a memory of taking Mrs. Neuhart - to be MR imaged - in North Carolina.
11. Mrs. Neuhart was also "imaged" - in Columbus, Ohio - and evaluated by a medical Neurologist - MD Xiasong Zhao.
12. Mrs. Neuhart was "imaged" - in the 45405 zip code area - related to a "shoulder pain" complaint; and, Radiologist Keith Bidwell - reported (in writing) [that] Mrs. Neuhart was suffering from a "torn Supraspinatus Tendon"; which, required surgery - to repair. [ ref. 8 ]
[ https://hansandcassady.org/mri-images/Imaging-Report-by-Bidwell-Susan-Neuhart-10-23-2017.pdf ]
13. Mrs. Neuhart did not undergo "surgery"; instead, opting to perform Yoga poses - in conjunction with instructions from various sources: [ MD Xiasong Zhao, Veterans Yoga Project, Yoga As Medicine - by McCall (a book) ]
14. Mrs. Neuhart's "torn Supraspinatus Tendon" did heal - without surgery. She suffers no continued pain - in the area - and, continues to perform Yoga poses daily - to counter-act the degenerative disc disease - she has been diagnosed with.
15. Sometime - prior to 5-18-2021 - both of Ms. Neuhart's Medical Doctors ( a General & a Neuologist ) did prescribe Mrs. Neuhart - to report to a local hospital ( Miami Valley hospital Ohio North) for a MRI and MRA - of Tesla 3.0 strength.
16. Mrs. Neuhart arrived - in a timely manner - for the procedures; But (they) were not performed - because Mrs. Neuhart did NOT have a "card" in her possession) - AND, no information - could be obtained - from the prescribing Medical Doctors.
Now, more than sixty days later - after developing HTML web pages (URLs 1, 2, ), contacting US-FDA and HHS agents
[ 1. SUSAN'S 6-3-2021 LETTER TO THE HHS-Secretary PDF ; 2. Susan's letter - to Agents of United States FDA, CDRH, CBER - dated 6-7-2021 [ pdf ] ; 3. Susan's letters - to Mizuho Medical CEO and their US agent ; to FDA-CDRH-CBER-HHS-version- 7- 20 -2021-PDFversion.pdf (PDF) ; 4. Susan's letter - to Jennifer A. Hart - US-FDA "agent" [ link] - AND, her US Congressman [ Mike Turner ( 7 -20-2021) ] - Mrs. Neuhart is still in search of the "card" - requested ( by "Ken" - at Miami Valley North Ohio Hospital (on 5-18-2021).
HER goal is to be safely "magnetic resonance" imaged (MRI and MRA) - so that her current Medical Doctors - can advise her .
Her current Medical Doctors cannot - re-schedule the required "magnetic resonance" events - without knowing (exactly) WHAT Sugita Aneurysm Clip [a"medical device"] was inserted into Susan Neuhart's brain - on Dec. 18-19, 2012. At this writing - the only identification known is:
" Catalog Number 1700110 CLIP 11.5 T2 STR 12 MM : Manufacturer Sugita " - from symbols that appear on a "Mission Health Systems" billing document [shown here ]
Susan continues to experience episodes of "VERTIGO" - while performing daily Yoga poses; which, are required - related to her degenerative disc disease diagnosis.
"... Beginnings of the Food and Drug Administration
The 1906 Act paved the way for the eventual creation of the Food and Drug Administration (FDA) and is generally considered to be that agency's founding date, though the agency existed before the law was passed and was not named FDA until later. "While the Food and Drug act remains a foundational law of the FDA mission, it's not the law that created the FDA. [Initially,] the Bureau of Chemistry (the precursor to the FDA) regulated food safety. In 1927, the Bureau was reorganized into the Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils. The FDIA was renamed the FDA in 1930. ...The law itself was largely replaced by the much more comprehensive Federal Food, Drug, and Cosmetic Act of 1938. ..."
The year 2006 marked the centennial of the law that gave rise to widespread consumer protection in the U. S., a law that in many ways was a hallmark of the Progressive Era.
Signed by President Theodore Roosevelt on June 30, 1906, the legislation that outlawed adulterated and misbranded food and drugs had traversed a difficult course that lasted 25 years and a hundred bills.
The law emerged as a result of dedicated work by many civic activists, state officials, health professionals, journalists, politicians, and others. However, few worked as hard, as long, and as effectively for the cause of consumer protection as Harvey Wiley, Chief Chemist of the Bureau of Chemistry in the U. S. Department of Agriculture, considered by many the father of the FDA.
The FDA recognized this anniversary in many diverse ways, from lectures, publications, and symposia, to musical performances, a bicycle race, and special web site commemorations. The documents here both recognize this key milestone in U. S. and FDA history and explore why the 1906 law was a turning point in the history of the American consumer. ..."
Janet Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021.
As Acting Commissioner, Dr. Woodcock oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products.
Dr. Woodcock began her FDA career in 1986, joining the agency’s Center for Biologics Evaluation and Research (CBER) as Director of the Division of Biological Investigational New Drugs, as well as serving as CBER’s Acting Deputy Director for a period of time. She later became Director of the Office of Therapeutics Research and Review in CBER, which included the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis during her tenure.
In 1994, Dr. Woodcock was named Director of the FDA’s Center for Drug Evaluation and Research (CDER), overseeing the center’s work that is the world’s gold standard for drug approval and safety. There she led many of the FDA’s drug initiatives, including introducing the concept of risk management as a new approach to drug safety; modernizing drug manufacturing and regulation through the Pharmaceutical Quality for the 21st Century Initiative; advancing medical discoveries from the laboratory to consumers more efficiently under the Critical Path Initiative; and launching the Safety First and Safe Use initiatives designed to improve drug safety management within and outside the FDA, respectively.
In 2004, Dr. Woodcock became Deputy Commissioner and Chief Medical Officer in the Office of the Commissioner. Later she took on other executive leadership positions in the Commissioner’s Office, including Deputy Commissioner for Operations and Chief Operating Officer.
In 2007, Dr. Woodcock returned as Director of CDER until she was asked to lend her expertise to “Operation Warp Speed” for developing therapeutics during the COVID-19 pandemic, such as evaluating the potential benefits of monoclonal antibody treatments for certain COVID-19 patients. From late 2020, she split her time advising “Operation Warp Speed” on advancing COVID-19 therapeutics while also serving as the Principal Medical Advisor to the Commissioner on key priorities on behalf of the Office of the Commissioner.
Dr. Woodcock holds a Bachelor of Science in chemistry from Bucknell University (Lewisburg, PA), and a Doctor of Medicine from the Feinberg School of Medicine at Northwestern University Medical School (Chicago). She also completed further training and a fellowship in rheumatology, as well as held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She is board certified in internal medicine.
Dr. Woodcock has been bestowed numerous honors over her distinguished public health career, most notably: a Lifetime Achievement Award in 2015 from the Institute for Safe Medication Practices; the Ellen V. Sigal Advocacy Leadership Award in 2016 from Friends of Cancer Research; the Florence Kelley Consumer Leadership Award in 2017 from the National Consumers League; and the 2019 Biotechnology Heritage Award from the Biotechnology Innovation Organization and Science History Institute. ..."
Dear Dr. Woodcock (Janet) - ( Acting Commissioner of Food and Drugs [FDA] )
Congratulations on being named "Acting Commissioner of Food and Drugs" on January 20, 2021 - in the Presidential Administration - of Biden - Harris.
My name is Susan Neuhart. I am a retired American citizen - living near Dayton, Ohio.
I have been contacting various persons - in the FDA (since June 7, 2021 ) related to information [that I (and my Medical Doctors) require] - so they can advise me - on my medical care. I have written two letters ( 1, 2 ) - which, detail my perspective on the situation. I am NOT a medical professional. I am retired from a long career - as a "Software Engineering Technical Writer". I have done other things (also). They are detailed - on my personal web site. https://hansandcassady.org/ . ( I did contact my US Congressional Representative [Ohio 10] YOU MAY HEAR FROM HIS OFFICE ) Coincidently - I heard from FDA agents [ within hours of contacting Mike.
... I realize [that] they are constrained - in what they 'can' and 'can not' do - by the US Code of Federal Regulations - and other US laws.
However, in essence - what I am seeking is information [that ] will not only HELP me - but thousands - of other Americans.
For example, Your staffer " Ms.Jennifer A. Hart" - of [FDA] Division of Import Operations - did contact me ( 7-22-2021) previously and THE DIVISION (also) responded (to me) ton : 7-22-2021 . IN fact, the information Ms. hart provided me with - enabled me to go to documents - which may enable me to inform my medical doctors.
~ I WANT TO THANK HER ! ~ she is a credit to your organization!
She ALSO provided me with suggested avenues to persue - which I will attempt. [ emphasis added by me ]
Unfortunately the [FDA] Division of Import Operations cannot provide answers to most of these questions. [see 8 questions below]
Questions ask by Susan 7-21-2021 - which Jennifer refers to:
The questions - and information required - from aneurysm clip manufacturers - include - but, are not limited to: 1) Exactly - what model of aneurysm clip was placed near the middle cerebral artery of my brain (December 2012)? Its "placement" - by my talented neurosurgeon ( Victor Perry MD ) - saved my life!
2) Who is responsible for maintaining the clip insertion detailed records generated - at the time of the installation? My hospital billing - only contained general information - related to a aneurysm clip. The Asheville, NC surgeon - of interest - is now located in offices - in Fresno California.
3) If the "specific record" was never generated - or, is missing - how can the information be determined now?
4) That is, was the aneurysm clip - approved by the FDA - required - to contain product identyfing information?
[ A product identifier - a "serial number" - of sorts ( https://en.wikipedia.org/wiki/Serial_number ) ]
5) A mico-chip - about the size of a grain of rice - was inserted to my pet - by his veterinarian. It was my understanding [that] should it be necessary - his body could be scanned with an ultra-violet device "reader/scanner" - AND, information specific (to him) - would appear on a screen - to aid his treatment and recovery.
6) The ability to permanently "bar-code" very small objects - such as an aneurysm clip - with meaningful symbols and information - has existed - since the 1970s.
7) On the other hand, if no aneurysm clip - approved for use in the USA - contains "product identyfing information" - at all - there is no purpose in retreiving the installed medical device - for topological or physical review - and, any surgery should be post-poned until clip failure - at a future hemorrhagic event.
8) [ PRODUCT END OF LIFE ] How would "clip failure" be experienced - by the individual - with an installed aneurysm clip? For example, I have been experiencing VERTIGO events - since April of 2021. These events are currently isolated - to my performance of certain YOGA poses. I perform Yoga poses daily - at my Medical Doctor's advice - to prevent the symptoms of degenerative disc disease [that] I have been diagnosed with. At present, there is no "cure" for degenerative disc disease.
CONTINUED - FROM JENNIFER A. HART (FDA)...
...
You will need to speak to the hospital and surgery center to obtain all medical records which may include the information about your surgery, what was implanted any documentation that would be required by the hospital. The billing department will likely not have that information. [ IN PROGRESS 7-23-2021 ]
FDA only requires manufacturers to track certain devices. I don't see these clips on the list of tracked devices. FDA would not have records of the specific device implanted. Here is a link to that guidance document with a list of devices: https://www.fda.gov/media/71205/download
For specific labeling and specifications of the device which may include end of life device information, you will need to submit a Freedom of Information request (FOI) of the all 510k files for the particular brand/model and manufacturer or request this specific information from the manufacturer: https://www.fda.gov/regulatory-information/freedom-information
I think in order for the manufacturer to provide you with specific information you may need to obtain the information from the hospital on lot code, brand of device and date of surgery.
For anything specific on how the device is regulated or requirements for the clips, you will need to reach out to DICE:
Other Agents who have messaged me [ by Email ] in response: THANK YOU!
Sheryl Lard-Whiteford, Ph.D. ,
Associate Director for Quality Assurance, CBER Ombudsman, Center for Biologics Evaluation and Research : US FDA : CBEROmbudsman@fda.hhs.gov
Dan Krainak, Ph.D. ,
Team Lead | Lead Biomedical Engineer, Division of Radiological Health | OHT7 Office of Product Evaluation and Quality
Joseph Milone, PhD
Senior Scientific Reviewer/Regulatory Health Scientist ,
Office of Combination Products (OCP), Office of the Commissioner (OC) - U.S. Food and Drug Administration
US Agent: Richard Chadwick : MIZUHO AMERICA, INC. ( https://www.zoominfo.com/p/Richard-Chadwick/5202595315 )
30057 Ahern Avenue, Union City, CA US 94587 :: Phone: 510 3244500 ext 150
https://www.google.com/maps/@37.6082024,-122.0765818,3a,75y,58.98h,90t/data=!3m6!1e1!3m4!1snOV0LufI_SKm4Hf6q8-J8g!2e0!7i16384!8i8192
"... Ron Chabot talks about his new job at ETIAM Corp.
by Loren Bonner, DOTmed News Online Editor | April 10, 2013
ETIAM Corp., a medical image connectivity company, announced the appointment of Ron Chabot as vice president of business development. He spoke with DOTmed News about his new job.
[ https://www.healthimaging.com/topics/enterprise-imaging/medical-image-connectivity-company-etiam-offers-dicom-file-tips
"... Medical image connectivity company ETIAM offers DICOM file tips to healthcare professionals - Published on: June 24, 2014 ..." ]
DMN: What's your background? RC: 20 years of medical device and health care communications experience having served as worldwide director of sales and marketing for Radionics/Tyco Healthcare, general manager and marketing director for Integra Neurosciences, and president and COO for Mizuho America.
DMN: How long have you been working in the industry? RC: 20 years of experience in health care.
DMN: What are your areas of interest? RC: My main area of focus with ETIAM will be working directly with physicians and building a distribution channel to accelerate the adoption of ETIAM Connect, the company's Image Exchange Solution. I also specialize in commercialization and new product/service launch, sales and distributor management and strategic market planning.
DMN: What are your goals as vice president of business development for ETIAM? RC: To continue our expansion and the advancement of patient care by providing high quality medical networking solutions to physicians and their patients in the U.S.
DMN: What excites you most about the industry these days? RC: The advancement of patient care through the benefits associated with electronically sharing medical images -- namely giving patients control over their own medical information, enabling them to receive same day second medical opinions, reducing the number of scans taken, and additional harmful radiation exposure. ..."
"... Master Blanket/Contract Vendor Distributor List
Vendor ID Vendor Name Preferred Delivery Method Vendor Distributor Status
00001725 Mizuho America Email Active
Master Blanket/Contract Controls Master Blanket/Contract Begin Date: 07/01/2014 Master Blanket/Contract End Date: 06/30/2019
Cooperative Purchasing Allowed: No
Organization Department Dollar Limit Dollars Spent to Date Minimum Order Amount
ARMC1 - Arrowhead Regional Medical Center ARMC - Arrowhead Regional Medical Center $150,000.00 $65,030.58 $0.00
Item Information
Print Sequence # 1.0, Item # 1: Aneurysm clips, Day-Bailes suction tubes, malleable disposable probes and associated supplies used in neurosurgery. Not to exceed $150,000 for the terms dates Effective July 1, 2014 through June 30, 2019. 3PS - Sent
NIGP Code: 475-22 ... Clips, Wound (Not for Use in Automatic Suturing Instruments) Req # / Item #: RARMC11459114 / 1 ..."
00001725 - Mizuho America Joyce Pritchard
30057 Ahern Avenue
Union City, CA 94587 - US
Email: jpritchard@mizuho.com - Phone: (510)324-4500 - FAX: (510)324-4545
MIZUHO SALES! should be aware of my efforts - to obtain information related to the aneurysm clip [that] was inserted INto my brain ( December 18-19, 2012 ) .
I seek this information for health reasons. ... I am enlisting the help of my US Congressman AND the US FDA. Now retired - I did own a high-tech business - and, was in charge of "SALES". THUS, I appreciate the investments - any successful company must make - to maintain a reputation of safe and reliable products.
I DID contact your US Agent: Richard Chadwick [ CONFIRMATION ABOVE ] : MIZUHO AMERICA, INC. ( Indentified to me by the US-FDA agent Jennifer A. Hart );
However, I am not impressed with his USA offices: 30057 Ahern Avenue, Union City, CA US 94587
It appears [that] he literally operates out of a warehouse: https://www.google.com/maps/@37.6082024,-122.0765818,3a,75y,58.98h,90t/data=!3m6!1e1!3m4!1snOV0LufI_SKm4Hf6q8-J8g!2e0!7i16384!8i8192(PHOTO PROVIDED)
I have developed an HTML page - for PRESENTATION & easy reference: https://hansandcassady.org/SEND-TO-MRI-SAFETY.html
Please review my HTML page - fully - and, offer assistance - if you can.
In fact, the careful placement - of your Medical Device - by my NeuroSurgeon - helped to save my life. As you will see, my concern is that your installed Medical Device - threatens my life now.
Please assist your US Agent: Richard Chadwick - to respond wisely - and fully - to my enquiry. AND, also assist Mission Hospital (Asheville, NC - USA ) - NeuroSurgery Department with the information - they will be seeking. As a "high-tech" worker - in Silicon Valley software - for many years - I can also appreciate that sometimes language - can present barriers to understanding.
- Sincerely Susan Neuhart
3-30-13 HONGO
BUNKYO-KU, Tokyo JP 1130033 Owner/Operator Number: 90074147
Official Correspondent:
toshimi shiun ::
1) https://dmec.moh.gov.vn/documents/10182/1839553/upload_00082703_1502877043836.pdf?version=1.0
2) https://dmec.moh.gov.vn/documents/10182/9066844/upload_00011125_1545281060621.pdf?version=1.0&fileId=9070264
https://www.linkedin.com/in/toshimi-shiun-054335b2/?originalSubdomain=jp
https://www.linkedin.com/in/toshimi-shiun-054335b2/?originalSubdomain=jp
3-30-13 Hongo
Bunkyo-ku, Tokyo JP 1130033 Phone: 81-3-38153180
US Agent:
Richard Chadwick
MIZUHO AMERICA, INC.
30057 Ahern Avenue
Union City, CA US 94587 Phone: 510 3244500 ext 150 Email: rchadwick@mizuho.com
Sincerely,
Jennifer A. Hart
Information Duty Officer (IDO)
Import Technical Assistance Branch (ITAB)
Division of Import Operations
Office Of Regulatory Affairs
U.S. Food and Drug Administration
(301)796-0356
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify Division of Import Operations by email at:FDAImportsInquiry@fda.hhs.gov immediately.
From: Susan Cassady Neuhart <susanREDACT Sent: Wednesday, July 21, 2021 8:20 PM To: FDA Imports Inquiry <FDAImportsInquiry@fda.hhs.gov>;REDACT@hansandcassady.org>; Neuhart Hans <Hans@eig.net> Subject: As per your instruction RE: [EXTERNAL] ATTEMPT 2 - ACTION NEEDED- RE:FDA Approved Medical Device 11 US-FDA
( CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe. )
7-21-2021
TO: Jennifer A. Hart, Information Duty Officer (IDO)
Import Technical Assistance Branch (ITAB)
Division of Import Operations
Office Of Regulatory Affairs
U.S. Food and Drug Administration
I do not have a FDA "consumer complaint". I am seeking information (about a "medical device" - perhaps manufactured in Japan - approved by the US-FDA - and distributed in the USA. The "medical device" [commonly called an "aneurysm clip"] was installed - into my brain (December 2012) - and, I (and my medical doctors) must know information - about its "life cycle" - in-situ to a human - to prevent harm - from being inadvertently done to myself - and, thousands of other Americans. I AM TRYING TO PREVENT HARM.
As you may know, there are literally thousands of aneurym clips created by many manufacturers - all over the world. The various "models" have physical characteristics - important to neurosurgeons ( at the "surgical moment" of their selection ). Each clip's "physical characteristics" - are also important - related to diagnostic imaging ( the Tesla Flux - they can withstand, etc.); and, metal corrosion (caused by oxygen molecules interacting with metal ions - in the presence of moisture). The human brain is the most oxygen rich environment in the human body - and, it is moist. Aneurysm clips are "constituent systems": they consist of parts assembled - to the final product. They may be coated in titanium and/or contain titanium alloys. Even pure titanium experiences magnetic flux.
The questions - and information required - from aneurysm clip manufacturers - include - but, are not limited to:
1) Exactly - what model of aneurysm clip was placed near the middle cerebral artery of my brain (December 2012)? Its "placement" - by my talented neurosurgeon - saved my life!
2) Who is responsible for maintaining the clip insertion detailed records generated - at the time of the installation ? My hospital billing - only contained general information - related to a aneurysm clip. The Asheville, NC surgeon - of interest - is now located in offices - in Fresno California.
3) If the "specific record" was never generated - or, is missing - how can the information be determined now ?
4) That is, was the aneurysm clip - approved by the FDA - required - to contain product identyfing information? A product identifier - a "serial number" - of sorts?
( https://en.wikipedia.org/wiki/Serial_number )
5) A mico-chip - about the size of a grain of rice - was inserted to my pet - by his veterinarian. It was my understanding [that] should it be necessary - his body could be scanned with an ultra-violet device "reader/scanner" - AND, information specific (to him) - would appear on a screen - to aid his treatment and recovery.
6) The ability to permanently "bar-code" very small objects - such as an aneurysm clip - with meaningful symbols and information - has existed - since the 1970s.
7) On the other hand, if no aneurysm clip - approved for use in the USA - contains "product identyfing information" - at all - there is no purpose in retreiving the installed medical device - for topological or physical review - and, any surgery should be post-poned until clip failure - at a future hemorrhagic event.
8) How would "clip failure" be experienced - by the individual - with an installed aneurysm clip? For example, I have been experiencing VERTIGO events - since April of 2021. These events are currently isolated - to my performance of certain YOGA poses. I perform Yoga poses daily - at my Medical Doctor's advice - to prevent the symptoms of degenerative disc disease [that] I have been diagnosed with. At present, there is no "cure" for degenerative disc disease.
And, because the hospital billing document - identified "Sugita Aneurysm Clip" - I did contact - the Japanese company [that did manufacture] - a product by this name:
[ message: https://hansandcassady.org/V2-EMAIL-Mizuho-Medical-PDF-VERSION.pdf ] They (the company - in Japan) has not responded - at this writing. [ MIZUHO DID RESPOND !!! 7-27-2021 (CLICK TO SEE)] But, I am hopeful [that] they will - because, their product literature (circa 2020) - does indicate [that] they may have anticipated a need for a "product identifier" - on their clips.
( http://www.mizuhomedical.co.jp/products/ ?id=1459223043-814215 ) HOW THAT "PRODUCT INFORMATION" - CONTAINED ON THEIR ANEURYSM CLIP - CAN BE "READ" IS NOT INDICATED.
Thank you for your reply to my enquiry. I presume - other FDA agents - respect your efforts - AND, this is why my enquiry - was forwarded to you - as well as the "Japan" nexus. I note - in my records [that] I did previously contact YOU (also) - in June of 2021.
"... Subject RE: [EXTERNAL] ATTEMPT 2 - ACTION NEEDED- RE:FDA Approved Medical Device 11 US-FDA
From FDA Imports Inquiry
To REDACT@hansandcassady.org, Song, Ting, Rajan, Sunder, shingchunbenny.lam@fda.hhs.gov, Kainz, Wolfgang, Krainak, Daniel, OC Combination Products, FDA Imports Inquiry, CDRH Small Manu. Assistance, CDRH Registration and Listing, CDRH FURLS Date Today [ 7-21-2021 ] 16:32
Good Afternoon,
Thank you for contacting the Division of Import Operations. We appreciate your email and your commitment to protecting public health. To report adverse reactions or other problems with FDA-regulated products, contact the FDA Consumer Complaint Coordinator for the state in which you reside. The contact phone number for Texas is 855-630-2112.
Jennifer A. Hart
Information Duty Officer (IDO)
Import Technical Assistance Branch (ITAB)
Division of Import Operations
Office Of Regulatory Affairs
U.S. Food and Drug Administration
(301)796-0356
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information.
If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited.
If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify Division of Import Operations by email at: ( FDAImportsInquiry@fda.hhs.gov ) immediately.
Form: Health Information Exchange Contact Us Form
https://missionhealth.org/medical-professionals/hie/contact-us/
https://missionhealth.org/contact-us/
Need more information about the Patient Safety Institute ( Mission Hospital) ?
5. Call Dana Raines at 828-213-4822 or Dana.Raines@msj.org
SOURCE: US-FDA Agent : Jennifer A. Hart
"... You can also try to reach out to the official correspondent or the U.S. Agent for Mizuno Japan:
Establishment: MIZUHO CORPORATION
3-30-13 HONGO BUNKYO-KU Tokyo, JP 1130033
Registration Number: 3011547624
FEI Number*: 3011547624
Status: Active
Date of Registration Status: 2021
-- US Agent: Richard Chadwick, MIZUHO AMERICA, INC.
30057 Ahern Avenue
Union City, CA US 94587
Phone: 510 3244500 ext 150
6. Email: rchadwick@mizuho.com ..."
A. https://allpeople.com/cathi+durham_mission-health-system_25d-us < LIST Mission Hospital Contacts
My name is Susan Neuhart - AND, I am contacting you - at the direction of Jennifer A. Hart
( US-FDA Agent ) cite [ AND] as of 7-27-2021 - Mizuho Medical ( cite ). THEY BOTH STAND READY TO ASSIST YOU - AS NEEDED - TO HELP ME TO OBTAIN THE INFORMATION - [THAT] I SEEK - SO THAT MY PRESENT HEALTH CARE PROFESSIONALS ( Dr Goldstick & Sadikov ) - CAN ADVISE ME - BASED ON SCIENCE - regarding the VERTIGO events [that] I am experiencing. WE SEEK Tobtain a Patient Information CARD related to - the Aneurysm Clip - that was inserted to my brain - at Mission Hospital, Asheville, NC ( on December 18, 2012). As you may be aware, there do NOT exist any Email addresses - that are published for: "@missionhealth.org" [ < GOOGLE ] - Thus, I have prepared a "form" version - of this message - that directs THE READER - to the ON-line version - of the messag content - availabe here > https://hansandcassady.org/SEND-TO-MRI-SAFETY.html#PURSUIT%20OF%20HOSPITAL%20RECORDS%20-%20RELATED%20TO%20ANEURYSM%20CLIP%20BILLED
My Congressional Representative is: Mike Turner [OH10]. My US Senators are: Sherrod Brown and Rob Portman - please respond ( to them ) in kind for they have my permission to contact you and government agencies - as needed.
WE SEEK Tobtain a "Patient Information CARD" related to - the Aneurysm Clip - that was inserted to my brain - at Mission Hospital, Asheville, NC ( on December 18, 2012).
THE INFORMATION CONTAINED ON THIS CARD - WILL ENABLE TWO QUESTIONS - TO BE ANSWERED - VIA THE SCIENTIFIC DATA THAT WAS SUPPLIED - TO THE US-FDA - TO OBTAIN PERMISSION TO MARKET AND SELL A "MEDICAL DEVICE" IN THE UNITED STATES.
QUESTION 1) Can the Sugita Aneurysm Clip "an FDA Medical Device" ( installed in my brain - December of 2012 - AND described by Mrs. Walker [for billing purposes] ) - "move" - via "induction" potential ( by magnetic flux )- in the clip - by the MR prodcedures & strengths typically IN-USE today?
QUESTION 2) Has the clip's "metal" moleculecular constituents corroded to rust?
My Congressional Representative is: Mike Turner [OH10]. My US Senators are: Sherrod Brown and Rob Portman
- please respond ( to them ) in kind for they have my permission to contact you and government agencies - as needed.
Subject: I am NOT contacting Mission Health System - today - with a "complaint" - of any kind. Rather, I am seeking information - AND IT IS urgent < Date: 2021-07-29 19:11
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mISSION hOSPITAL - re: Susan Neuhart attachment required Susan Cassady Neuhart Today 09:31 443 KB
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Return Receipt (read): Mission Hospital patient Susan Neuhart - completed patient Information Request FORMS Susan Cassady Neuhart Today 09:14 3 KB
Thank YOU for contacting me. This is my AUTO-respond message @hansandcassady.org Today 09:03 1 KB
Mission Hospital patient Susan Neuhart - completed patient Information Request FORMS Susan Cassady Neuhart Today 09:03 987 KB
Return Receipt (read): I am NOT contacting Mission Health System - today - with a "complaint" - of any kind. Rather, I am seeking information
- AND IT IS urgent Susan Neuhart 7-29-2021 Thu 19:11 3 KB
Thank YOU for contacting me. This is my AUTO-respond message @hansandcassady.org Thu 19:11 2 KB
I am NOT contacting Mission Health System - today - with a "complaint" - of any kind. Rather, I am seeking information - AND IT IS urgent Susan Cassady Neuhart 7-29-2021 Thu 19:11 73 KB
Subject Not read: [Internet] Mission Hospital patient Susan Neuhart - completed patient Information Request FORMS
From Mission ROI
To Susan Cassady Neuhart
Date Today 09:30
Part 2.eml (~16 KB)winmail.dat (~5 KB)
This message is for the designated recipient(s) only. It may contain privileged, confidential, proprietary, or otherwise private information that is legally protected.
If you have received it in error, please notify the sender immediately and delete the original.
You are prohibited from using or distributing this email without permission. < THREAT? Thank you. This message was secured by Zix(R) . "Zix" : https://zix.com/
Subject Not read: [Internet] Mission Hospital patient Susan Neuhart - completed patient Information Request FORMS :: From Mission ROI
To Susan Cassady Neuhart
Date 7-30-2021 Today 09:30Message 2 of 806
"... Dear Mission Health System Representatives: MissionROI@cioxhealth.com , hcapsgmissionhealth@cioxhealth.com , MissionROI.mgmt@cioxhealth.com
... My name is Susan Neuhart ... as instructed > [ https://missionhealth.org/patients-visitors/patient-resources/medical-records/ ]
- ATTACHED ( TO THIS EMAIL ) ARE the completed patient Information Request FORMS ..."
THE documents are also posted to FOUR accessible Internet URLs - shown below: ( The "edited" version contains my signature. )
PLEASE "ACKnowledge" this Email for my record - of your RECEIPT. YOU may use: @HansANDcassady.ORG - for this ACK purpose ONLY.
Thank you - Susan Neuhart
- former patient of Mission Hospital, Asheville, NC - FOR "craniotomy" surgery AND placement of "aneurysm clip" - related to SAH@MCA stroke Event 12-18, 2012 TO: MissionROI@cioxhealth.com, hcapsgmissionhealth@cioxhealth.com, MissionROI.mgmt@cioxhealth.com,
https://hansandcassady.org/result-Dump-Trump.mp4 < VIDEO DUMP TRUMP >
AAAAAAAAAAAAAAAAAAAAAAAAAAAA
jpritchard@mizuho.com :: < FAILED
" ...We recommend contacting the person or service responsible for
looking after the recipient domain's email server directly. ... "
To: socialmedia@msj.org,
ROBIN.JONES4@HCAHEALTHCARE.COM,
ERIKA.PREZAS@HCAHEALTHCARE.COM, ANDREA.SLIVINSKI@HCAHEALTHCARE.COM,
Dana.Raines@msj.org,
rchadwick@mizuho.com,
jpritchard@mizuho.com, < FAILED
Subject: I am NOT contacting Mission Health System - today - with a "complaint" - of any kind. Rather, I am seeking information - AND IT IS urgent < Date: 2021-07-29 19:11
As clarified (below) - the US FDA and Mizuho Medical are assisting me: Thus, I specified "Mizuho Medical" US Agent: Richard Chadwick, MIZUHO AMERICA, INC. - as the MEDICAL INFORMATION "recipient" - so his records [re: assisting me ] are complete.
Please feel free - to copy the US-FDA - for your records.
The "Information REQUEST HANDLER Services" - you specify - are copied on this message * - And - as instructed - I will E-mail the completed Information Request FORMS to them.
My existing records reflect that Registered Nurse (RN) Kathryne Walker - of Mission Health System - did [on Dec. 19, 2012]
- acknowledge - ( by her name) a "billing record" ( page 21 of 22 ) of my craniotomy surgery - performed Dec. 18-19, 2012 - at Mission Hospital, Asheville, North Carolina - Emergency Surgical Services - by NeuroSurgeon Victor Perry. The record is here :
At this writing (7-29-2021) Dr. Victor Perry has offices in Fresno, California. [ his WEBsite ]
I "googled" [ Kathryne Walker RN Mission Health System (828) 213-1111 ]
- but, I can find no record - that confirms [ KathryneWalker, RN] is still associated with "Mission Health System".
In FACT, the actions [that] were taken - on [Dec. 18-19, 2012] - by Mission Health Systems staff - and NeuroSurgeon Victor Perry - saved my life! And, we ( my husband [ Hans Neuhart ] and I [ about ] ) will be forever grateful - for the people & technology - who made our "good results" possible. This begins with the person - who took my husband's frantic "911 call" - on Dec. 18, 2012. From that "911" call - severalcapable teams did "dispatch" - on various Emergency vehicles - on a snowy evening - and were capable of extricating me - from a hillside log home ( where my hands were clutched onto a stair railing) - and, my body was motionless - in a SAH@MCA stroke induced trauma state.
Your helicopter team - THEN air-lifted me to the top of Mission Hospital hospital - in downtown Asheville, NC.
At the rooftop "Emergency Entrance" - of that facility - my preparation for an emergency craniotomy procedure began. I recall being warmly embraced by a person - who reassured me - that - it was "... gonna be OK honey ...".
My long wet hair - for I was showering when my husband became concerned - was gently gathered (and cut) - and, my head - in the area of interest was shaved - and, an iodine cleanser applied. Oxygen was supplied (for me) - and, I was sedated.
My next memory - is from days (perhaps weeks) later - when I reached to feel my itching head - and, my hand encountered objects - attached to it - ONLY to prevent infection, ease pain and protect the sutures required. Nude - except for a gown - I needed to urinate - and, the kind human present - urged me to consider "just peeing" - into the diaper - that was in position. I think [that] I did urinate into the diaper supplied (that first day).
In the subsequent days - I was fed and bathed every day. At all times - kind assistance was offered - to me. But, I was also encouraged to return - to "normalcy" - to "come back" - and to "survive". As you are aware, "brain surgery" requires the severing of Neural Networks ( neurons ) - to access the area of interest. Thus, significant healing & re-growth - of neural pathways - is necessary.
My husband came every day - to visit - during my "in-patient" stay. And, I was made "presentable" - to my loving mate. The records - no doubt reflect - the exact number of days [that] I was held in "Intensive Care". It is my impression - it was longer than 30 days. I have a vague memory - of being taken to a "kitchen area" - where I was reminded of how to prepare food. I practised walking - while holding onto a railing for support. After "assessment interviews" - I was released - to my husband's care - at our log home.
He doted over me - in the first days. I remember comparing it - to the way [that] - a new "first time" mother - is attentive to her new born. I had been a "new mother" - when I was a teenager. I divorced the father of my only child - circa 1978 - and, went to college. Hans and I first met October 18, 1982 - when I interviewed - with the NCR Corporation - for a job. I got the job - and, Hans & I were married - in 1983. My daughter is (today) a happily married attorney - living in the Washington, DC area. Hans is a talented (now semi-retired) digital medical artist and "high-tech" worker; I am a fully retired Software Engineering Technical Writer. As "partners" - in every sense of the word - we have lived all over the United States - from California to Florida. We were both born in Ohio. The year "2021" marks our 39th year together.
But, returning to YEAR 2013 - and my "release" to his care and custody - after a SAH@MCA stroke event AND succcessful surgery [ at MISSION HOSPITAL, ASHEVILLE, NC] ...
Eventually, my loving husband - became able to breathe - without worry. For many weeks - he cooked all of our meals and cleaned. He has told me many times ... "I found a strength - that I did not know [that] I had." Hans accompanied me during each bath; And, he helped to wash and comb my remaining hair. He did our laundry - and, he dressed me.
After many months, related to our medical debts - our inability to perform paid work, etc. - we lost our "physical residence". My biological sister - offered us a "refuge" - in her lovely - large home - sited in Columbus, Ohio. We stayed there - for almost two years. After which, we secured a small single family residence - in zip code 45405.
During our residence - in Columbus, Ohio - I continued to "heal" - and became stronger. I also came into the care of Neurologist Xiasong Zhao MD. Medical Doctor Zhao is the first medical professional - to suggest [that] performing Yoga might help improve the balance and coordination issues - he observed.
I am fortunate [that] my husband [ Hans Neuhart ] began lifting weights - as a young person. He has attended "local gyms" - since I met him - in 1982; and, has continued that practise - through our 39+ years. We even owned and operated a gym "PhoeniX Fitness" ( located in Westerville, Ohio). Thus, Dr. Zhao's suggestion [for me] was fully supported - by Hans. Hans has never done "Yoga poses" - but, he encourages me to accompany him - to the local gym. I do not drive.
Because of my good out come (from SAH@MCA surgery) - I was surprised to learn - while doing Yoga activity - in public - [that] my near full re-habilitation - from such a stroke event - is statistiscally unusual. Trained nurses and doctors - that I have met - have remarked this. Today, the remaining scars - on my head - are my only external proof - that I underwent a "full craniotomy" - with entry through my right Sylvan Fissure - emergency medical surgery - in December of year 2012. I do not suffer from seizures - which is common. I take minmal medications.
Thus, I am NOT contacting Mission Health System - today - with a "complaint" - of any kind. Rather, I am seeking information.
As Ms. Walker's record (cited here and above) reflects - a "Sugita" Aneurysm Clip - Catalog Number 1700110 " 11.5 T2 STR 12 MM" was inserted into my brain - - at my emergency craniotomy surgery event Dec. 18-19, 2012 - Mission Hospital, Asheville, NC - by NeuroSurgeon Victor perry.
The placement of that "aneurysm clip" - that day - by my talented neurosurgeon (in association with the staff of Mission Medical) - helped to save my life; However, unless I can obtain the information [that] I seek - that same "Medical Device" - may now pose a threat - to my life.
Specifically, since April - of 2021 - I have been experiencing "VERTIGO" during my Yoga poses - also prescribed for degenrative disc disease - which most Americans 67+ years of age have some form of.
The cause of this VERTIGO - must be determined. ( My ears are "clear" - according to Medical Examination by Otoscope ear exam. )
However, my current Medical Doctors - or, any responsible medical institution CANNOT perform a "magnetic resonance diagnostic procedure" - upon me; without INFORMATION - related to the potential for harm (to me) - by the installed clip - AND "current condition" of the clip ( as detailed by Ms. Walker above).
QUESTION 1) Can the Sugita Aneurysm Clip "an FDA Medical Device" ( installed in my brain - December of 2012 - AND described by Mrs. Walker [for billing purposes] ) - "move" - via "induction" potential ( by magnetic flux )- in the clip - by the MR prodcedures & strengths typically IN-USE today?
In fact, on May 18, 2021 - the operators of a Power 3.0 Tesla MR device - opted NOT TO BEGIN MY SCHEDULED DIAGNOGSTIC PROCEDURES - RELATED TO THEIT WELL-EDUCATED CONCERN. I have never possessed the "card" they requested - that day. In fact, I only learned [that] such a card MAY exist - in my instance - related to my research - to contact you today.
NOTE: Mizuho Medical's 7-27-2021 response ( image ) - clarifies [that] they are ready, willing and able to work with "YOU" [the hospital were the surgery was performed] to prepare a "replacement card" - if needed.
The agents - that I have contacted - at Mizuho - are reflected here: [link] The Mizuho representative - who responded - does not identify themself - in the 7-27- 2021 message; But, the US FDA Representative detailed - who the "US Government Representative Agent" - for Mizuho is - in her reply [ LINK].
Jennifer A. Hart: Information Duty Officer : Import Technical Assistance Branch (ITAB) : Division of Import Operations : Office Of Regulatory Affairs : U.S. Food and Drug Administration :(301)796-0356
You may know Mizuho Medical is an International Company - with "home" offices in Japan.
MIZUHO Medical SELLS AT LEAST 99 TYPES OF "Aneurysm Clips" ( in America). They are presented in their 12 page brochure > ( pdf )
I focus on PAGE 7 ( of their brochure ) - for my HTML web sit page viewers ( here )
- because it presents the "INSTRUCTIONS" [that] Mission Hospital was suppose to follow.
I presume, MIZUHO MEDICAL - made the effort - to create page 7 INSTRUCTIONS - so the danger ( I am now in ) does NOT occur frequently.
Details (of my 5-18-2021 event - an attempt to be MR imaged - at my local hospital ) are contained in my 6-3-2021 message to our US Secretary HHS
( Xavier Becerra ): [ https://hansandcassady.org/Email-HHS-Secretary%20-PDF-VERSION-6-3-2021-final-6-3-2021-FINAL.pdf ]
"Jennifer A. Hart, Agent for the US-FDA - also - specifies I need: "lot code" :: "brand of device" :: "date of surgery."
Mrs Walker's billing document specifies the "brand of device" and "date of surgery"
THUS, what I require - on an official document - is "lot code"
As you can see: Mizuho's "Patient Information CARD"
- is designed to hold the specific clip's information - via a label (they supply) - which should be transferred
- AND, Misuho provides an image detailing how each clip is [in fact] laser etched - with identifying information. [ link ]
QUESTION 2) Has the clip's "metal" moleculecular constituents corroded to rust? Nearly nine plus [9+] years have past - since the clip was installed (on Dec-18, 2012). As you may know - "titanium ALLOY"- unlike pure "titanium" - is a "ferromagnetic" material - composed of metal and titanium minerals. And, all metal corrodes (to rust) in the presence of oxygen and moisture. The human brain has more oxygen molecules - than any other organ - throughout each day - AND, it is moist. As the US-FDA Agent ( Jennifer A. Hart) makes clear - what I require is "end of PRODUCT life device information" - that Mizuho Medical has - for the Medical Device - approved by the US-FDA.
And, Mizuho Medical has - AT LEAST 99 TYPES OF Aneurysm Clips approved by the US-FDA. Each one - has unique characteristics. They are presented in their 12 page brochure > ( pdf )
THUS - I need my "Patient information card" AND/OR to know the information [that] was recorded to my MIZUHO Sugita Aneurysm Clip "patient card" - per, their "End User" Instruction card ( example shown here ). The clip's unique and individual details - including lot number and specification - will enable the FDA & Mizuho to further assist me - if necessary.
HOWEVER, IF MISSION HOSPITAL (Asheville, NC) FAILED TO FOLLOW THE PRODUCT USE INSTRUCTIONS - PROVIDED ( by Mizuho) - I LOOK FORWARD TO WORKING WITH MISSION HOSPITAL AGENTS - TO OBTAIN THE INFORMATION [THAT] I AND MY MEDICAL DOCTORS REQUIRE - so [that] I may be safely DIAGNOSED & imaged - by "magnetic resonance" devices - at this time.
As I have previously disclosed - I did work for Battelle Research - at the US-ARMY Owned Medical Research and Evaluation Facility [ MREF - sited in West Jefferson, Ohio - circa 1986 ]. I designed and developed software - related to scheduling the "secure" facility - for animal study models of testing and research. Thus, I am aware - "Mizuho Medical" would have conducted "animal" studies - to be approved (by the US-FDA) to market and sell their Medical Device ( The Sugita Titanium Alloy Aneurysm Clip 'T2' ) - in America. This required design, testing & DATA is why - of course - a seemingly "simple" clip object - has such a significant price: ( averaging $1,500 USD each). I get it! Many hundreds of "scientific manhours"- went into each clip's design and manufacture. And, I respect the meticulous scientific processes required. ( https://hansandcassady.org/sUGITA-1700110-COPY-7-27-2021-06.JPG )
IMPORTANT: Mission Health System tranferred my care to Neurologist "Duff Rardin" ( DURING 2013, on the staff of Mission Health Systems). My "in-patient" care was also provided (in part) - by a Mission Hospital Affililate: "CARE Partners". They - or Dr. Rardin - may be in possession of the "patient card" - that was created on December 19, 2012? And, I think [that] I may have undergone MRI and CATscan procedures - at Mission Health Systems. Perhaps, these persons [staffers] retained "the card". When we moved to the Columbus, Ohio area - Neurologist Xiasong Zhao MD - took over my "stroke related" care. He may have had me undergo - MR diagnostics - to be able to suggest - that Yoga could be beneficial (to me). And, at some point, I was diagnosed with progressive degenertive disc disease.
And, in fact - Yoga did appear to benefit me. For example, I was diagnosed [ in writing - by Radiologist Keith Bidwell ] -with a Supraspinatus Tendon tear - based on a MRI - of my sholder ( 2017 ). ( PDF of REPORT ) Prefering not to undergo "surgery" - I studied various sources - did Yoga poses - and, the "painful tear" - has appeared to heal. The pain is gone. Can a "hupraspinatous tendon tear" heal - by doing Yoga poses? At some point - this reported "tear" - will have to be re-imaged ( I presume ). Again, the detailed "aneurysm clip" information - will be required.
At this time - now living 90+ miles (from Columbus, Ohio) - my Neurologist is Lawrence GoldStick MD. My General Family physician is Polina Sadikov MD. Related to my continuing VERTIGO & an annual follow ups - they want me to undergo an MRA/ MRI diagnostic procedures. I have undergone both of these diagnostic procedures - in previous years - without complication. However, the potential of "rust" formation [related to the titanium alloy] and the NEW - more powerful - magnetic resonance technology was not an issue - in the early years following my SAH@MCA stroke event - of 2012.
I need this INFORMATION Mizuho Sugita Aneurysm Clip "Patient Information" - hopefully - in your possession - As soon as possible.
MY EMAIL IS : (REDATED here - but supplied on the submitted FORM and Email Contact )
MY PHYSICAL ADDRESS IS : ( REDATED here - but supplied on the submitted FORM )
SOURCE: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078506/
"... Brain Oxygen Consumption and Regulation : The human brain is one of the most metabolically active organs in the body, despite not performing mechanical work like skeletal muscle or the heart. The normal human brain consumes 3.5 ml of O2 per 100 g of brain tissue per minute, a value which remains constant throughout periods of wakefulness and sleep. This relatively high rate of oxygen consumption is appreciable when compared to the metabolic rate of the entire body. The average man weighs 70 kg and consumes ∼250 ml of O2 per minute in the resting state. With the average human brain weighing 1400 g (∼2% of total body weight), it therefore consumes ∼49 ml O2 per minute, or 20% of total body oxygen consumed while at rest (21a, 46, 82) (Table 1). Within the brain, oxygen consumption is highly dynamic and region specific. ..."
Form: Health Information Exchange Contact Us Form
https://missionhealth.org/medical-professionals/hie/contact-us/
https://missionhealth.org/contact-us/
Need more information about the Patient Safety Institute ( Mission Hospital) ?
5. Call Dana Raines at 828-213-4822 or Dana.Raines@msj.org
SOURCE: US-FDA Agent : Jennifer A. Hart
"... You can also try to reach out to the official correspondent or the U.S. Agent for Mizuno Japan:
Establishment: MIZUHO CORPORATION
3-30-13 HONGO BUNKYO-KU Tokyo, JP 1130033
Registration Number: 3011547624
FEI Number*: 3011547624
Status: Active
Date of Registration Status: 2021
-- US Agent: Richard Chadwick, MIZUHO AMERICA, INC.
30057 Ahern Avenue
Union City, CA US 94587
Phone: 510 3244500 ext 150
6. Email: rchadwick@mizuho.com ..."
A. https://allpeople.com/cathi+durham_mission-health-system_25d-us < LIST Mission Hospital Contacts
https://www.fda.gov/regulatory-information/freedom-information < PROCESS INFORMATION
https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request < HOW TO, WHERE TO MAKE REQUEST & ONLINE URL CITE
- https://www.accessdata.fda.gov/scripts/foi/FOIRequest/index.cfm
( Noncommercial Use Requestors, Such as Representatives of the News Media, Public Interest Groups, and Educational and Noncommercial Scientific Institutions:
Duplication charges at the same rates listed above with no charge for first 100 pages of duplication.
Other Requestors, Including Consumers:
Search and duplication charges at rates listed above with no charge for the first two hours of search and the first 100 pages of duplication. )
https://foiaonline.gov/foiaonline/action/public/request
https://foiaonline.gov/foiaonline/action/public/request < form
https://www.fda.gov/regulatory-information/freedom-information/foia-fees < FEES
"... Noncommercial Use Requestors, Such as Representatives of the News Media, Public Interest Groups, and Educational and Noncommercial Scientific Institutions:
Duplication charges at the same rates listed above with no charge for first 100 pages of duplication.
Other Requestors, Including Consumers:
Search and duplication charges at rates listed above with no charge for the first two hours of search and the first 100 pages of duplication.
... FOIA requestors may have to pay fees covering some or all of the costs of processing their request. Requestors may want to include the maximum dollar amount they are willing to pay. If the fees exceed the maximum amount stated, FDA will contact the requestor before filling the request. Requestors are generally billed for fees after their requests have been processed; however, if total fees are expected to exceed $250.00 FDA may require payment in advance of processing.
Commercial Use Requestors:
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Duplication: $ .10 per page for standard-size paper or actual cost per page for odd-size paper.
Certifications: $10 each.
Computer Charges: actual cost for time involved.
Electronic Forms/Formats: actual cost for form/format requested. ..."
eXEMPTIONS> https://www.foia.gov/faq.html#exemptions
"... The nine exemptions are described below.
Exemption 1: Information that is classified to protect national security.
Exemption 2: Information related solely to the internal personnel rules and practices of an agency.
Exemption 3: Information that is prohibited from disclosure by another federal law.
Exemption 4: Trade secrets or commercial or financial information that is confidential or privileged.
Exemption 5: Privileged communications within or between agencies, including those protected by the:
Deliberative Process Privilege (provided the records were created less than 25 years before the date on which they were requested)
Attorney-Work Product Privilege
Attorney-Client Privilege
Exemption 6: Information that, if disclosed, would invade another individual’s personal privacy.
Exemption 7: Information compiled for law enforcement purposes that:
7(A). Could reasonably be expected to interfere with enforcement proceedings
7(B). Would deprive a person of a right to a fair trial or an impartial adjudication
7(C). Could reasonably be expected to constitute an unwarranted invasion of personal privacy
7(D). Could reasonably be expected to disclose the identity of a confidential source
7(E). Would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law
7(F). Could reasonably be expected to endanger the life or physical safety of any individual
Exemption 8: Information that concerns the supervision of financial institutions.
Exemption 9: Geological information on wells. ..."
https://www.fda.gov/regulatory-information/freedom-information
"... Freedom of Information (FOI) Request ..."
"... For specific labeling and specifications of the device which may include end of life device information, you will need to submit a Freedom of Information request (FOI) of the all 510k files for the particular brand/model and manufacturer or request this specific information from the manufacturer: https://www.fda.gov/regulatory-information/freedom-information ..."
"Clip User Card for Patient Support after Surgery" "Mizuho"
[copy for editing & RESEARCH] ...You will need to speak to the hospital and surgery center to obtain all medical records which may include the information about your surgery, what was implanted any documentation that would be required by the hospital.
hospital on lot code, brand of device and date of surgery.
Dear Mission hospital "surgery center" Asheville, NC ] I need to "... obtain all medical records ... related to "information about my surgery ( date: performed by: ) At this time, I am experiencing VERTIGO - when performing Yoga poses - as prescribed by my Medical professional. What I need to know is exactly what aneurysm clip was implanted to my brain - to stop the aneurysm - and save my life - AND, any documentation that YOU required - from the vendor. My hospital billing cited [ image ] ... "end of life device information" .
For specific labeling and specifications of the device which may include end of life device information, you will need to submit a Freedom of Information request (FOI) of the all 510k files for the particular brand/model and manufacturer or request this specific information from the manufacturer: https://www.fda.gov/regulatory-information/freedom-information
[copy for editing & RESEARCH] ...You will need to speak to the hospital and surgery center to obtain all medical records which may include the information about your surgery, what was implanted any documentation that would be required by the hospital.
Dear [hospital] I need to "... obtain all medical records ... related to "information about my surgery ( date: performed by: ) At this time, I am experiencing VERTIGO - when performing Yoga poses - as prescribed by my Medical professional. What I need to know is exactly what aneurysm clip was implanted to my brain - to stop the aneurysm - and save my life - AND, any documentation that YOU required - from the vendor. My hospital billing cited [ image ]. "end of PRODUCT life device information"
For specific labeling and specifications of the device which may include end of life device information, you will need to submit a Freedom of Information request (FOI) of the all 510k files for the particular brand/model and manufacturer or request this specific information from the manufacturer: https://www.fda.gov/regulatory-information/freedom-information *
* Dear Mizuho Medical ( the "Sugita Anuerysm Clip" manufacturer ) - based on information supplied (to me) - at this time - [I am seeking more details] - your product "Sugita Anuerysm Clip" was installed to my brain - on December 18-19, 2021- during a surgery - to save my life - threatened - at that time - by a SAG@MCA event. I was flown to the top of the Mission hospital "surgery center" - located in Asheville, NC.
The surgery was performed by Neurosurgeon Victor Perry.
After gradual rehabilitation, I was given instruction ( by my medical doctor : neurologist ( Xiasong Zhao ) to perform Yoga poses - to continue my journey - to full recovery.
There are two 510ks for sugita clips listed under Mizuno Corporation, Japan. I can't guarantee these were the versions of devices used.
"AVM" - https://www.mayoclinic.org/diseases-conditions/brain-avm/symptoms-causes/syc-20350260
" Sugita AVM Microclip"
SOURCE: http://www.mizuhomedical.co.jp/products/?id=1463989324-346501
"... Sugita AVM Microclips are dependable and made of Elgiloy for superior durability and spring elasticity.
To prevent damage and to facilitate handling, the Clip is individually seated in a heat-resistant silicone sponge and packaged in a metal container, which is fully autoclavable.
Clips are made to have a holding force within the predetermined range of 50-70g. ..."
"Elgiloy" : https://en.wikipedia.org/wiki/Elgiloy
the 510k holder is Mizuho America Inc..
I think in order for the manufacturer to provide you with specific information you may need to obtain the information from the hospital on lot code, brand of device and date of surgery.
For anything specific on how the device is regulated or requirements for the clips, you will need to reach out to DICE:
"... Subject RE: [EXTERNAL] ATTEMPT 2 - ACTION NEEDED- RE:FDA Approved Medical Device 11 US-FDA
From FDA Imports Inquiry
To shansandcassady.org, Song, Ting, Rajan, Sunder, shingchunbenny.lam@fda.hhs.gov, Kainz, Wolfgang, Krainak, Daniel, OC Combination Products, FDA Imports Inquiry, CDRH Small Manu. Assistance, CDRH Registration and Listing, CDRH FURLS Date Today [ 7-21-2021 ] 16:32
Good Afternoon,
Thank you for contacting the Division of Import Operations. We appreciate your email and your commitment to protecting public health. To report adverse reactions or other problems with FDA-regulated products, contact the FDA Consumer Complaint Coordinator for the state in which you reside. The contact phone number for Texas is 855-630-2112.
Jennifer A. Hart
Information Duty Officer (IDO)
Import Technical Assistance Branch (ITAB)
Division of Import Operations
Office Of Regulatory Affairs
U.S. Food and Drug Administration
(301)796-0356
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information.
If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited.
If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify Division of Import Operations by email at: ( FDAImportsInquiry@fda.hhs.gov ) immediately.
For specific labeling and specifications of the device which may include end of life device information, you will need to submit a Freedom of Information request (FOI) of the all 510k files for the particular brand/model and manufacturer or request this specific information from the manufacturer: https://www.fda.gov/regulatory-information/freedom-information
"As of 3/12/2020, please submit all requests through our online portal (link below) rather than mail, fax, or courier, to ensure timely logging of your request."
Please do not submit your request more than one time; if you submit by fax, do not also submit online and/or by mail, etc.
All FOIA requests must be in writing and should include the following information:
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B. A description of the records being sought. The records should be identified as specifically as possible. A request for specific records that are releasable to the public can be processed much more quickly than a request for "all information" on a particular subject. Also fees for a more specific and limited request will generally be less.
C. A statement concerning willingness to pay fees, including any limitations.
Questions relating to FOI requests may be addressed to the Division of the Freedom of Information Offices at (301) 796-3900.
All FOIA requests must be in writing. Requests should be mailed to the following address:
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Food and Drug Administration
Division of Freedom of Information
Office of the Executive Secretariat, OC
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Rockville, MD 20857
Or requests may be sent via fax to: fax number (301) 827-9267. ( If you experience difficulty sending a fax, please call (301) 796-3900. )
NEW! Requesters can now submit a FOIA request online:
"... FDA Freedom of Information Act (FOIA) FDA Home
The 1996 amendments to the Freedom of Information Act (FOIA) mandate publicly accessible "electronic reading rooms" with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.
Before submitting an FOIA request, please check to see if the information you are looking for is already available on FDA's Web site. ( DONE & ASSISTED BY Jennifer A. Hart )
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The collection of this information is authorized by the Freedom of Information Act (FOIA, 5 U.S.C. § 552). The collected information is used by FOIA staff to respond to your requests, and by appeals officials and members of the Office of the General Counsel. Provision of the requested information is voluntary (as that word is used by the Privacy Act of 1976), but may be required in order to process and respond to your request. Failure to provide your personally identifying information may result in FDA’s inability to respond to your request. A full list of the agency’s routine uses (disclosures) of the PII you submit is available at [this link].
TO: Jennifer A. Hart, Information Duty Officer (IDO)
Import Technical Assistance Branch (ITAB)
Division of Import Operations
Office Of Regulatory Affairs
U.S. Food and Drug Administration
I do not have a FDA "consumer complaint". I am seeking information (about a "medical device" - perhaps manufactured in Japan - approved by the US-FDA - and distributed in the USA. The "medical device" [commonly called an "aneurysm clip"] was installed - into my brain (December 2012) - and, I (and my medical doctors) must know information - about its "life cycle" - in-situ to a human - to prevent harm - from being inadvertently done to myself - and, thousands of other Americans. I AM TRYING TO PREVENT HARM.
As you may know, there are literally thousands of aneurym clips created by many manufacturers - all over the world. The various "models" have physical characteristics - important to neurosurgeons ( at the "surgical moment" of their selection ). Each clip's "physical characteristics" - are also important - related to diagnostic imaging ( the Tesla Flux - they can withstand, etc.); and, metal corrosion (caused by oxygen molecules interacting with metal ions - in the presence of moisture). The human brain is the most oxygen rich environment in the human body - and, it is moist. Aneurysm clips are "constituent systems": they consist of parts assembled - to the final product. They may be coated in titanium and/or contain titanium alloys. Even pure titanium experiences magnetic flux.
The questions - and information required - from aneurysm clip manufacturers - include - but, are not limited to:
1) Exactly - what model of aneurysm clip was placed near the middle cerebral artery of my brain (December 2012)? Its "placement" - by my talented neurosurgeon - saved my life!
2) Who is responsible for maintaining the clip insertion detailed records generated - at the time of the installation ? My hospital billing - only contained general information - related to a aneurysm clip. The Asheville, NC surgeon - of interest - is now located in offices - in Fresno California.
3) If the "specific record" was never generated - or, is missing - how can the information be determined now ?
4) That is, was the aneurysm clip - approved by the FDA - required - to contain product identyfing information? A product identifier - a "serial number" - of sorts?
( https://en.wikipedia.org/wiki/Serial_number )
5) A mico-chip - about the size of a grain of rice - was inserted to my pet - by his veterinarian. It was my understanding [that] should it be necessary - his body could be scanned with an ultra-violet device "reader/scanner" - AND, information specific (to him) - would appear on a screen - to aid his treatment and recovery.
6) The ability to permanently "bar-code" very small objects - such as an aneurysm clip - with meaningful symbols and information - has existed - since the 1970s.
7) On the other hand, if no aneurysm clip - approved for use in the USA - contains "product identyfing information" - at all - there is no purpose in retreiving the installed medical device - for topological or physical review - and, any surgery should be post-poned until clip failure - at a future hemorrhagic event.
8) How would "clip failure" be experienced - by the individual - with an installed aneurysm clip? For example, I have been experiencing VERTIGO events - since April of 2021. These events are currently isolated - to my performance of certain YOGA poses. I perform Yoga poses daily - at my Medical Doctor's advice - to prevent the symptoms of degenerative disc disease [that] I have been diagnosed with. At present, there is no "cure" for degenerative disc disease.
They (the company - in Japan) has not responded - at this writing. But, I am hopeful [that] they will - because, their product literature (circa 2020) - does indicate [that] they may have anticipated a need for a "product identifier" - on their clips.
( http://www.mizuhomedical.co.jp/products/ ?id=1459223043-814215 ) HOW THAT "PRODUCT INFORMATION" - CONTAINED ON THEIR ANEURYSM CLIP - CAN BE "READ" IS NOT INDICATED.
Thank you for your reply to my enquiry. I presume - other FDA agents - respect your efforts - AND, this is why my enquiry - was forwarded to you - as well as the "Japan" nexus. I note - in my records [that] I did previously contact YOU (also) - in June of 2021.
"... Subject RE: [EXTERNAL] ATTEMPT 2 - ACTION NEEDED- RE:FDA Approved Medical Device 11 US-FDA
From FDA Imports Inquiry
To susanREDACT..., Song, Ting, Rajan, Sunder, shingchunbenny.lam@fda.hhs.gov, Kainz, Wolfgang, Krainak, Daniel, OC Combination Products, FDA Imports Inquiry, CDRH Small Manu. Assistance, CDRH Registration and Listing, CDRH FURLS Date Today [ 7-21-2021 ] 16:32
Good Afternoon,
Thank you for contacting the Division of Import Operations. We appreciate your email and your commitment to protecting public health. To report adverse reactions or other problems with FDA-regulated products, contact the FDA Consumer Complaint Coordinator for the state in which you reside. The contact phone number for Texas is 855-630-2112.
We also encourage you to report this problem in MedWatch, which is FDA's medical product safety reporting program for health professionals, patients, and consumers: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
Sincerely,
Jennifer A. Hart
Information Duty Officer (IDO)
Import Technical Assistance Branch (ITAB)
Division of Import Operations
Office Of Regulatory Affairs
U.S. Food and Drug Administration
(301)796-0356
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information.
If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited.
If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify Division of Import Operations by email at: ( FDAImportsInquiry@fda.hhs.gov ) immediately.
TO: Jennifer A. Hart, Information Duty Officer (IDO)
Import Technical Assistance Branch (ITAB)
Division of Import Operations
Office Of Regulatory Affairs
U.S. Food and Drug Administration
I do not have a FDA "consumer complaint". I am seeking information (about a "medical device" - perhaps manufactured in Japan - approved by the US-FDA - and distributed in the USA. The "medical device" [commonly called an "aneurysm clip"] was installed - into my brain (December 2012) - and, I (and my medical doctors) must know information - about its "life cycle" - in-situ to a human - to prevent harm - from being inadvertently done to myself - and, thousands of other Americans. I AM TRYING TO PREVENT HARM.
As you may know, there are literally thousands of aneurym clips created by many manufacturers - all over the world. The various "models" have physical characteristics - important to neurosurgeons ( at the "surgical moment" of their selection ). Each clip's "physical characteristics" - are also important - related to diagnostic imaging ( the Tesla Flux - they can withstand, etc.); and, metal corrosion (caused by oxygen molecules interacting with metal ions - in the presence of moisture). The human brain is the most oxygen rich environment in the human body - and, it is moist. Aneurysm clips are "constituent systems": they consist of parts assembled - to the final product. They may be coated in titanium and/or contain titanium alloys. Even pure titanium experiences magnetic flux.
The questions - and information required - from aneurysm clip manufacturers - include - but, are not limited to:
1) Exactly - what model of aneurysm clip was placed near the middle cerebral artery of my brain (December 2012)? Its "placement" - by my talented neurosurgeon - saved my life!
2) Who is responsible for maintaining the clip insertion detailed records generated - at the time of the installation ? My hospital billing - only contained general information - related to a aneurysm clip. The Asheville, NC surgeon - of interest - is now located in offices - in Fresno California.
3) If the "specific record" was never generated - or, is missing - how can the information be determined now ?
4) That is, was the aneurysm clip - approved by the FDA - required - to contain product identyfing information? A product identifier - a "serial number" - of sorts?
( https://en.wikipedia.org/wiki/Serial_number )
5) A mico-chip - about the size of a grain of rice - was inserted to my pet - by his veterinarian. It was my understanding [that] should it be necessary - his body could be scanned with an ultra-violet device "reader/scanner" - AND, information specific (to him) - would appear on a screen - to aid his treatment and recovery.
6) The ability to permanently "bar-code" very small objects - such as an aneurysm clip - with meaningful symbols and information - has existed - since the 1970s.
7) On the other hand, if no aneurysm clip - approved for use in the USA - contains "product identyfing information" - at all - there is no purpose in retreiving the installed medical device - for topological or physical review - and, any surgery should be post-poned until clip failure - at a future hemorrhagic event.
8) How would "clip failure" be experienced - by the individual - with an installed aneurysm clip? For example, I have been experiencing VERTIGO events - since April of 2021. These events are currently isolated - to my performance of certain YOGA poses. I perform Yoga poses daily - at my Medical Doctor's advice - to prevent the symptoms of degenerative disc disease [that] I have been diagnosed with. At present, there is no "cure" for degenerative disc disease.
They (the company - in Japan) has not responded - at this writing. But, I am hopeful [that] they will - because, their product literature (circa 2020) - does indicate [that] they may have anticipated a need for a "product identifier" - on their clips.
( http://www.mizuhomedical.co.jp/products/ ?id=1459223043-814215 ) HOW THAT "PRODUCT INFORMATION" - CONTAINED ON THEIR ANEURYSM CLIP - CAN BE "READ" IS NOT INDICATED.
Thank you for your reply to my enquiry. I presume - other FDA agents - respect your efforts - AND, this is why my enquiry - was forwarded to you - as well as the "Japan" nexus. I note - in my records [that] I did previously contact YOU (also) - in June of 2021.
SINCERELY
- Susan Neuhart
YOUR Original REPLY MESSAGE FOLLOWS: ( viewing size reduced )
"... Subject RE: [EXTERNAL] ATTEMPT 2 - ACTION NEEDED- RE:FDA Approved Medical Device 11 US-FDA
From FDA Imports Inquiry
To susanREDACT..., Song, Ting, Rajan, Sunder, shingchunbenny.lam@fda.hhs.gov, Kainz, Wolfgang, Krainak, Daniel, OC Combination Products, FDA Imports Inquiry, CDRH Small Manu. Assistance, CDRH Registration and Listing, CDRH FURLS Date Today [ 7-21-2021 ] 16:32
Good Afternoon,
Thank you for contacting the Division of Import Operations. We appreciate your email and your commitment to protecting public health. To report adverse reactions or other problems with FDA-regulated products, contact the FDA Consumer Complaint Coordinator for the state in which you reside. The contact phone number for Texas is 855-630-2112.
We also encourage you to report this problem in MedWatch, which is FDA's medical product safety reporting program for health professionals, patients, and consumers: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
Sincerely,
Jennifer A. Hart
Information Duty Officer (IDO)
Import Technical Assistance Branch (ITAB)
Division of Import Operations
Office Of Regulatory Affairs
U.S. Food and Drug Administration
(301)796-0356
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information.
If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited.
If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify Division of Import Operations by email at: ( FDAImportsInquiry@fda.hhs.gov ) immediately.
14 CONTACT CATEGORIES:
#
01 HOLD BROADCAST MEDIA ( HOLD UNTIL UNSATISFACTORY GOVERNMENT RESPONSE IS APPARENT ) HOLD
02 Politicians: My Ohio Congressman Mike Turner, Senator BROWN 01, Senator PORTMAN 02, US President: BIDEN
03 MEDICAL DEVICE (MRI RELATED) MANUFACTURERS - Email version
04 MAGNETIC RESONANCE DEVICE MANUFACTURER - CONTACT: FORM VERSION
05 MEDICAL Safety TRAINING - PROFESSIONALS (MRI SPECIFIC)
06 MEDICAL Professors & Teachers
07 MEDICAL Publishers
08 Research ScientistS - America & France
09 Academic Medical Centers
10 Hospital - Technology Sites
11 US-FDA
12 CDRH Management - HHS/fda
13 Center for Biologics Evaluation and Research
14 Regulatory Support Service (example)
FFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFF
#
Group name
Status
HHHHH
01
BROADCAST MEDIA ( HOLD UNTIL UNSATISFACTORY GOVERNMENT RESPONSE IS APPARENT ) HOLD
HOLD ON THIS GROUP
BROADCAST MEDIA - "INVESTIGATIVE" REPORTING ( https://www.ire.org/contact/ )
Anderson Cooper (CNN) :: Email address:tips@cnn.com
Chris Cuomo > FORM : https://chriscuomo.com/ask-chris/
Huff Post > https://img.huffingtonpost.com/securedrop "RAISE AN ARMY" - "Persuasion and argumentation" [ https://www.uwgb.edu/clampitp/Phils%20Site/Internet_Broadcast/pasyl.htm ]
02
Politicians: My Ohio Congressman Mike Turner < DONE, BROWN 01, PORTMAN 02, US President: BIDEN
THIS GROUP (DONE EMAILED)
jeff.shuren@fda.hhs.gov
Douglas.KellyMD@fda.hhs.gov
Ellen.Flannery@fda.hhs.gov
Elizabeth.Hillebrenner@fda.hhs.gov
Melissa.Torres@fda.hhs.gov
Nicole.Ellis@fda.hhs.gov
Nancy.Braier@fda.hhs.gov
Olga.Claudio@fda.hhs.gov
Cathy.Oliveri@fda.hhs.gov Jerry.Menikoff@hhs.gov >>>>> done Julia.Gorey@hhs.gov
douglas.diekema@seattlechildrens.org
ocrmail@hhs.gov
OCRMedia@hhs.gov [ PDF VERSION OF REQUEST ] via Jerry.Menikoff@hhs.gov (done)
THIS GROUP (DONE EMAILED)
Peter.Marks@fda.hhs.gov < DIRECTOR
email@asn-online.org < Witten, Celia ASSISTANT DIRECTOR
khi@asn-online.org < Witten, Celia ASSISTANT DIRECTOR
cberombudsman@fda.hhs.gov
NOTE!! I HAVE NOT CONTACTED THE MEDIA YET (Group number 01); AND, I WILL DECIDE WHEN I WANT TO COMMUNICATE - WITH THEM ...
THE "STAKEHOLDERS" [THAT] I HAVE CONTACTED - MAY USE MY EMAIL - WHICH, THEY HAVE ;
and FINALLY, NEVER MESS WITH AN AMERICAN - WHO KNOWS "HTML" & SEVERAL COMPUTER PROGRAMMING LANGUAGES
Dear US Agents of (the) United States FDA, CDRH, CBER
My name is: Susan Neuhart. I am a retired American SENIOR. What follows is a version of a message – that I have already sent to: US Health and Human Services Secretary - Xavier Becerra; VIA his POSTED AGENT: ( Jerry.Menikoff@hhs.gov ) when I learned [that] Secretary Becerra has authority over your activities – and “final authorization” decisions.
I use this understanding “advisedly”. My personal experience is in American private business. (IE – I was never a “civil servant” -although I did want to work for the EPA. )
I am “retired” – from a long professional career – as a “Software Engineering Technical Writer”. I did NOT document “Medical Device” USE; However, my work experience – is relevant – as I will explain.
Similar (to HHS Secretary Becerra), I was the first (of my mother’s seven children) – to attend College. My father died – related to “Mesothelioma” – when I was ten years old (1964). He had an established business – carpentry AND placing “wall-paper’ coverings in Columbus, Ohio homes. He performed the work himself. He (also) bid and won a contract to remove “asbestos” – from Columbus Public Elementary Schools. I was his “helper” – in the private homes – of Columbus. When he passed, my mother received Social Security “survivors’ benefits” AND some small monthly amount - related to his death - from work with The Columbus Public School System. Despite the money (which fed us) - my mother sank into a very deep depression – at 48 years of age. [ PHOTO: Mary & Milo Gerald CassAdy ] She task me – when I showed interest – with explaining (to her) – what had happened to my father. I Graduated from the University of Wisconsin’s Green Bay campus – with a B.S. in Environmental Science & Communications (1982). In the course of my education – I learned – and informed my mother – what had harmed my dad.
THE FOLLOWING SPECIFICS ARE RELATIVE TO MY COMPLAINT ( THAT - I have already shared with the Secretary & posted to MEDwatch. – confirmation image ):
1) I ARRIVED - AS INSTRUCTED - on 5-18-2021 - FOR "BACK-2-BACK" MRI & MRA RADIOLOGICAL diagnostic PROCEDURES – as SCHEDULED BY MY MEDICAL DOCTORS [SADIKOV & GOLDSTICK] – AT A LOCAL HOSPITAL (Miami Valley North Ohio)
2) This hospital offers many Magnetic Resonance scanning devices; However, the medical procedures were scheduled (by my doctor’s offices) - to take place - UTILIZING the 3 TESLA Magnetic Resonance (MRI) Imaging DEVICES offered.
3) In fact, the scheduled medical procedures did not take place (that day). Because, A) I did not possess a "card" - which was requested – by my “MRI Patient Safety Team”; and, B) my attempt - to supply [the limited information – [that] I did have] - was NOT accepted. [image cite]
4) After endeavoring for, almost one-hour, to "find information" - related to the specific aneurysm clip – [image cite] - installed in my brain (in 2012) - a member of my "Patient Safety Team" - informed me – “with regret”- [that] they could not "go forward" - and, perform the ordered tests - because of a "Tesla concern” [they had]. It was – at this point [that] I was informed the MR scanning device (scheduled to be used on me) was a “3 TESLA” MAGNETIC RESONANCE power unit.
5) Surprised - that I even knew what "Tesla units" were - I re-assured the agent - that - I was capable - of finding the “required information” – to “re-schedule” - and, we parted.
I am in search of this information now – as an assigned “mission”. [ PDF ]
As you can see (here), I have contacted the “clip’s” manufacturer – located in Japan [with sales offices – also in California, USA.]
[ https://hansandcassady.org/Brain-Implant-information.html#Mizuho%20Medical%20co%C2%A0Japan%C2%A0%20&%20America ] –
THEY HAVE NOT RESPONDED - YET.
But – because my tone – is “polite”; my request is “sincere” – and, I am informed – I REMAIN HOPEFUL [THAT] THEY WILL RESPOND.
6) I began – trying to “SAFELY re-schedule” – for an MRI (5-18-2021), by doing internet research & documenting my findings.
I am capable of creating web sites & HTML pages [albeit slowly] – thus, I did so – to organize and document my efforts – and aid communications – SUCH AS THIS:.
7) In fact, prior to my "retirement" - I was often employed to create END-USER Manuals - for American companies – related to software and/or technology products - they had developed. Such “documentation” was typically deployed – using HTML and web sites.
8) Our current US Secretary of Health and Human Services – has an extensive legal background. As a “legal professional” – I felt he may know [that] - in addition to providing “INSTRUCTIONS” - for the USE of a product (by the designated "END-USER”) - the TECHNICAL WRITER'S responsibilities - often have LEGAL IMPLICATIONS. Specifically – an American PRODUCT'S “END-USER Manual” often contains "warnings" - and statements of "Failure To Follow" – which are designed to ANTICIPATE, defend, ABSOLVE and protect - the issuing company – in a US Court-of-LAW – if necessary.
9) Thus, it is with this experience AND perspective [that] - I did contact Secretary Becerra – And, (also) a sense of ALARM! – as I will explain.
10) Specifically, I am legally “dis-abled” -- but almost re-habilitated – from a SAH@MCA stroke event- that occurred [ on Dec 18, 2012]. This kind of stroke is statistically rare (in Caucasian women) – which, I think I am – and, few people survive (them – at all) – without some permanent mental and physical disability.
NOTE: My maternal Grandmother is (the) “Zora Elizabeth Sprouse (nee Miller – Roby 1883-1953 ). She was married to George Sprouse. They had 13 children – before George’s death – circa 1928. At which time, my mother – and her siblings – were placed into the Franklin County OHIO Children’s Home.
I give this detail – because my survival & rehabilitation (from SAH@MCA stroke) – are “unusual” – I have been told.
Moreover, I was born with “Pectus carinatum” – which, I out-grew – at my puberty – as is typical – for persons born with this birth defect.
In fact, I became an elementary school tetherball champion – because – one of the last things – my father did – [before his death] was build me a regulation tether ball court – in the “back yard” – of our rented house. This was long before “Venus and Serena Williams”. My father did not want a “crippled kid” – and, he believed – what the doctors had said: “Milo, … brace her … and straighten her – and, some day – she’ll be just like any other kid.” They did… And, at puberty (when my body started making the correct molecules) I mostly was – “like the other kids” .
11) Indeed, I was (again) very fortunate [that] Victor Perry MD [ a neurosurgeon] – was on “emergency duty” – when my Life-Flight helicopter delivered me to the top – of Asheville, NC’s Mission Hospital.
12) Dr. Perry met the helicopter, gave swift instructions, performed the required craniotomy surgery – and installed a FDA approved “aneurysm clip” – to my brain’s main cerebral artery – at the site of the burst aneurysm. [SAH@MCA]
13) After the surgery, I was placed into an induced “cold” coma – to enable healing to take place and reduce anticipated swelling.
14) After one month of “intensive care” – I was “phase released” (from the hospital) – to my husband’s care. He did a wonderful job! A strong man – until I was able to walk – he carried me. ( image Hans )
15) In the next weeks and months – my brain literally rewired itself – related to neural “pathways “– that were disrupted by the required surgical entry [through the Sylvian fissure] – to the areas of interest. If metal screws were used to secure my “craniotomy bone flap”– or remain installed, I do not know.
[ https://mayfieldclinic.com/pe-craniotomy.htm ]
16) After one year of rest and rehabilitation (in my husband’s care) – I began to perform “Yoga poses” – at the suggestion of my Columbus, Ohio neurologist – Xiaosong Zhao, MD- AND, the US Veterans YOGA project.
17) I bought books - related to practicing “YOGA as medicine” – and, continued to physically heal. I purchased a URL and began to build a web site – [ https://hansandcassady.org/ ] – to engage my mind – in subjects [that] interest me. This includes politics!
18) I very early supported Kamala Harris. Joe is lucky [that] she said “Yes”; and, this encouraged my support for “their team”.
19) I made videos in support of their candidacy. I hope [that] they helped. VIDEO My videos are popular – with Seniors – at the YMCA – and, THEY VOTE!…
20) FINALLY, after my recent INTERNET investigation (related to my Aneurysm Clip- installed in 2012) – AND – the 3+ Tesla Magnetic Resonance (MR) imaging device – that, I was scheduled to be “scanned” in [ cite], I AM ALSO - NOW AWARE - OF HOW PRECARIOUSLY CLOSE - I CAME - TO BEING EVEN MORE DISABLED - OR KILLED - HAD THE SCHEDULED [MRI/MRA] PROCEDURES GONE FORWARD.
21) REITERATING! …After an earnest effort - by the members of my "MRI Patient Safety Team" - I was "regrettably" informed [that] they were not able to locate information - specific to my installed aneurysm clip - identified in my 2012 Hospital Discharge Documentation. [cite] – which they had. Indeed, we were all – so “earnest” – “nice” and” polite” (that day). I am certain they had no intentions of harming (or killing) me. But – had we gone forward – this would have been the result! That is, the aneurysm clip (identified in my hospital discharge/billing document) is approved – by the FDA 1999 – for “UP TO” 1.5 Tesla power. NOTE: Celia Witten ( ASSISTANT DIRECTOR - Center for Biologics Evaluation and Research -- ALSO REFERRED TO AS: CBER) is the signatory on the 1999 “FDA” approval document. Thus, I am copying her organization – also.
In SUMMARY, my personal research - SUBSEQUENT TO THE PREVIOUS EVENTS [stated 1 through 21 above] - indicates – [that] an Agency - of US Health and Human Services (the US-FDA) has approved the USE of technology that represents "A CLEAR AND PRESENT DANGER" to many "unsuspecting" Americans” – when sited in the “profit center” or “diagnostic areas” of a hospital ..
The record is clear – [cite ] Americans have been harmed – by this short-sighted US-FDA decision – to permit the sale AND siting of NEW and MORE POWERFUL MAGNETIC RESONANCE IMAGING DEVICES – IN HOSPITALS – AND DIAGNOSTIC SERVICE CENTERS. I was obviously fortunate – to encounter an ALERT and responsible “Patient Safety Team” – at my local hospital; however, it should be noted: A) I tried to supply information – to encourage them to proceed; B) the team made numerous inquiries (also) – to go forward. AND C) My own doctors scheduled the procedures – on those “3-TESLA” power machines - [that] -had THE SCHEDULED PROCEDURES gone forward – could have moved (by MAGNETIC FLUX ) and/or reacted with - the earlier approved aneurysm clip installed in my brain – near my middle cerebral artery.
INDEED - I DO - based on my research - SIMULTANEOUSLY APPRECIATE THE DESIRE TO UTILIZE "IMPROVED TECHNOLOGY" - AS IS THE CASE - IN THIS INSTANCE. The “results” are more definitive – etc.
HOWEVER, TO IMPLEMENT - "IMPROVED TECHNOLOGY" - WHICH MAY SAVE LIVES - WHILE SIMULTANEOUSLY TAKING AND DAMAGING OTHER AMERICAN LIVES – AND, AT A MINIMUM, PLACING SOME AMERICANS IN GREAT JEOPARDY - IS WRONG!
As a retired “Technical Writer” I ask:
“Why was this NEW & POWERFUL MAGNETIC RESONANCE (MR) "technology" so blithely approved (with a “wink and a nod”) - without complementary SAFEGUARDS “built-in” (as a REQUIREMENT! TO USING IT)? (I do not know…).
However, ( THIS MEDICAL TECHNOLOGY’S) continued and UN-abated USE & PRACTICE (without proper safeguards!) - is "reckless" - and it should be addressed IMMEDIATELY!
Because of my work "experience" (described above) - I am keenly aware of THE Magnetic Resonance Imaging (MRI) Device manufacturers - desire to "shift the legal responsibility" - for “SAFETY” - to END USERS .
However - this product's instantiation [AS AN “FDA APPROVED MEDICAL DEVICE”] with complementary monetary interests ALSO exist.
That is, these “diagnostic medical devices” – become “profit centers” – in hospitals – where “speed” & “throughput” is emphasized. AND - the resulting harms - may PREVENT or disable the injured from pursuing "justice" – in a US court of LAW - AND/OR even – cause the victim's - death.
TO BE CLEAR - I AM NOT (AT THIS TIME) "INJURED" - OR WAS NOT "INJURED" - ON 5-18-2021 – BUT (THIS WAS), ONLY BECAUSE THE "PATIENT SAFETY TEAM" ASSIGNED (TO ME) - ACTED RESPONSIBLY - - while simultaneously expressing 'regret" AND “searching for information” – to proceed – as my Medical Doctors had requested.
In fact, even I - and my husband – were urging them – to consider my previous MRI experiences. And, my husband (Hans) and I – did previously - literally joke [that] I have a “titanium” clip installed in my head (like the bionic woman – from television) – Unaware [in fact] of the dangers – inherent- in such an installation – WE WERE …
I am ALSO (today) aware – from my research – [that] my “safety team’s actions - probably did cause their employer [ a local hospital ] - to lose income - in a typical "profit center" - of the overall hospital operation. That is, hospital’s and related businesses – can bill Medicaid & Medi-CARE several thousand dollars – for “completed” Magnetic Resonance related diagnostic procedures. The most expensive – that (I saw) – was $6,000.
Thus, ALL those in my case - should be commended - for their good actions; AND, my case (also) illustrates (the need) for firm "RULES – that should be brought into existence – by HHS (and FDA). That is, “Rules” - which can prevent and STOP further harm - IN SIMILAR CIRCUMSTANCES. AND THOSE, WHO BREAK OR IGNORE THESE "RULES"- SHOULD BE PROSECUTED - BY A JURY - OF THE VICTIM'S "PEERS" – to the fullest extent of the law… [ US & International ]
Finally, in part - I accepted this responsibility ( to notify YOU! ) of the dangers (literally approved by the FDA) - from a member of my SAFETY team ; because of my unique qualifications.
THAT IS, In addition to my "profession" & “work experience”-previously disclosed - above – I was employed by General Electric - related to "GE military systems" - being deployed – in the mid-eighties. However, as you may know, “GE Health CARE” also manufactures several Magnetic Resonance (MR) device models. [ cite, IMAGE ]
My hope is, (that) - in a uniform USA market place - GE will act responsibly – for the “greater good”. They are certainly “situated” - to design and implement - a “Medical Device User SAFETY Interface [MDUSI]” - that will not permit their powerful RADIATION devices to operate ( AT ALL! ) - unless specific "SAFETY" criteria are met. THAT IS, in conjunction with a "automated Medical Device - Operation Approval System" - the occasional serious harms (now occurring) could be prevented - entirely. In fact, I was ‘ask for’ a “card” (which I had no knowledge of). Perhaps a “medical alert” tag – could be clipped onto American’s ears – who have metal installed. Such systems already exist for our pets.
In fact, I was also a "software system designer" - for - the University of Wisconsin (1981) and Battelle Research (1986+). I designed and implemented - the school's “Automated Weather Station” – for the US National Science Foundation; AND - the US Army's Medical Research & Evaluation Facility's(MREF) “Automated Scheduling System” - managed by Battelle Research - for the US Army’s Chemical Weapons Defense Efforts .
This is among my FIRST NOTIFICATIONS - to the US-Government. I have previously notified the aneurysm clip manufacturer – AND, the hospital – to compliment and THANK THEM! I printed and mailed – the document [that] I sent to our Secretary of HHS – to US Medical Doctors: Sadikov, Goldstick, Perry (today). THEY ARE ALL GOOD DOCTORS!
However, I hope to successfully message (by email) - and alert - ALL of the aspects - of the related MEDICAL DEVICE industry (shown here) – which I uncovered – in my internet rearch :
AND, other concerns urge me on (also): I am now over-due – for a routine “follow-up” using MRI/MRA diagnostic scans – and, experiencing symptoms of Vertigo – when performing certain Yoga poses. My neurologist ( Goldstick )wants me – to get these scans done SAFELY – and soon. Thus, time is of the essence!
I am aware [that] [United States FDA, CDRH, CBER ] may need to interview me. I am legally disabled (since the 2012 stroke event) and prefer Email contact: REDACT@handSANDcassady.org - to establish a time and mode. Which, please ONLY suggest a means – that is “documentable” via HTML- which, I may “publish” – on my personal web site. Please allow sufficient time. I am VERY “detail oriented”, ASK LOTS OF QUESTIONS – and, get “mixed-up”.
I LOOK FORWARD TO WORKING WITH YOU- TO ADDRESS THE ISSUES PRESENTED.
Please act soon! - to prevent the "harm" - that I was able to avoid - because of the brave and conscientious "Patient Safety Team" assigned to me - at Miami Valley Hospital North - Ohio.
My research indicates, [that] other Americans (including children!) have NOT been so lucky. In fact, any American - with metal installed - in their body is at risk; including - soldiers – with shrapnel and bullet fragments.
THAT IS, Americans with metals (as constituents of “systems”) - safe and non-reactive - in a lower Tesla Unit era - may be "unsuspecting" - AS WAS I [that] the more powerful magnetic systems [approved by the FDA] – can literally move and/or cause harmful reactions – INCLUDING BURNS- in the metal residing in them. For example, my installed (2012) ANEURYSM clip was approved -by the FDA (in 1999) for 1.5 maximum Tesla Unit operating environments.
[ https://www.accessdata.fda.gov/cdrh_docs/pdf/k990202.pdf ]
At a minimum, the "ignorance" - surrounding this dangerous (to some) NEW MRI technology must be eliminated. Which- I believe, this "ignorance" could be eliminated - with a HHS National Press Release - and EDUCATION EFFORT. I noted [that] there is an "education" complement - to the FDA organization.
Surely, Americans will clamor for information - about the "SAFETY" - of the metal installed in them - if alerted - and informed – by your offices – using media outlets – available to them. FOR EXAMPLE, I believe, [that] AMERICANS WILL RESPOND TO A MESSAGE CITING:
"NEW POWERFUL MAGNETS" APPROVED BY THE US GOVERNMENT - THAT ARE CAUSING METALS - PREVIOUSLY INSTALLED (TO AMERICANS ) - TO REACT AND/OR MOVE -pose a DANGER!"
Again, I look forward to working with your agents. Please use my Email – to notify me of specific arrangements.:
US Agent: Richard Chadwick - MIZUHO AMERICA, INC.
30057 Ahern Avenue - Union City, CA US 94587
Phone: 510 3244500 ext 150
[ http://www.medicalproductguide.com/companies/7612/mizuho-america-inc ] < MIZUHO MEDICAL PRODUCT GUIDE
Email: rchadwick@mizuho.com
My bad, Mr. Chadwick - I sent you an Email with a non-working LINK.
This one works:
https://hansandcassady.org/SEND-TO-MRI-SAFETY.html < THIS PAGE
I look forward to working with MIZUHO AGENTS - TO OBTAIN THE INFORMATION [that] I REQUIRE.
"... ASTM F136 - 13 Standard Specification for Wrought Titanium-6
Aluminum-4Vanadium ELI (Extra Low Interstitial)
Alloy for Surgical Implant Applications (UNS R56401) ..."
"... ISO 5832-3 ..." :
SOURCE: https://www.iso.org/standard/66637.html
"... ISO 5832-3:2016 Implants for surgery — Metallic materials — Part 3:
Wrought titanium 6-aluminium 4-vanadium alloy
... ABSTRACT :: ISO 5832-3:2016 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti 6-AI4-V alloy) for use in the manufacture of surgical implants. ...NOTE The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.
..." https://www.iso.org/obp/ui/#iso:std:iso:5832:-3:ed-4:v1:en
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Coincidently - I heard from FDA agents [ within hours of contacting Mike.
99 types < mizuho-sugita-titanium-BROCHURE.JPG
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