SBS - The Best Value in QMS software

FDA safety scandal: 50K hidden reports of heart device malfunctioning - May 2019

Marc

Fully vaccinated are you?
Staff member
Admin
#1
Since news of the scandal broke, the FDA says it will shut down the reporting system.
By: Beth Mole - Ars Technica

FDA safety scandal: 50K hidden reports of heart device malfunctioning

The Food and Drug Administration allowed the maker of a faulty implantable heart device to secretly log 50,000 malfunction incidents, according to a series of investigations by Kaiser Health News.

The device—the Sprint Fidelis, made by Medtronic—consists of a pair of wires and a defibrillator to jolt the heart into a regular rhythm. But doctors found that it was giving patients random, harmful zaps and sometimes failed during actual cardiac emergencies.

The list of exempted devices includes common and controversial devices. Some of these are typically implanted into patients and used in common surgeries, such as pelvic mesh, surgical staples, balloon pumps for improving circulation, breathing machines, and breast implants.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Last edited:

Watchcat

Trusted Information Resource
#3
Wimpy move on FDA's part, IMO, probably caving to political pressure. This will not benefit anybody, just waste FDA resources processing reports individually instead of in bulk, and, to the extent that those resources are drawn away from meaningful oversight activities, it will do some harm.

It was an intelligent effort to reduce some of that bureaucratic inefficiency that people are always complaining about. But intelligent efforts to reduce bureaucratic inefficiency don't make sensational headlines, and no good deed goes unpunished.
 

Highground

Involved In Discussions
#4
Hi,

I don't have time to write a lengthy post disproving some of the themes in this story, but I strongly recommend taking KHN's stories with a hefty pinch of salt. For example: Discovery of "hidden" FDA database of malfunctions

The Medtronic pacemakers story - as horrible as it is - is old news (2007) and there's nothing secretive about the FDA's Alternative Summary Reporting Program (which is also old news).
This Medtronic pacemaker story is why I moved into Regulatory on a permanent bases. My Dad had this pacemaker for a year putting up with the random zaps until they finally replaced the wires.
 
Thread starter Similar threads Forum Replies Date
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational The US FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device Medical Device and FDA Regulations and Standards News 0
M Informational The USFDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
M FDA News FDA Safety communication – Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings Medical Device and FDA Regulations and Standards News 0
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0
M Medical Device News FDA news - 17-09-18 - Agency's commitment to studying breast implant safety Other US Medical Device Regulations 0
S FDA Class I Medical Device Safety and Efficacy Data Requirements Other US Medical Device Regulations 5
M Demonstrating battery safety in 510(K) submission for the FDA Other US Medical Device Regulations 9
S Medical Device Aging & Safety Questions by FDA Other US Medical Device Regulations 6
M Level of Concern (FDA) vs. Software Safety Classification(IEC) US Food and Drug Administration (FDA) 3
S New Draft FDA Guidance on Enforcement of INDs - Safety Reporting Requirements US Food and Drug Administration (FDA) 0
Ajit Basrur FDA to disclose more details on Drug, Food Safety US Food and Drug Administration (FDA) 0
B US FDA Food Security - Safety Checklist Food Safety - ISO 22000, HACCP (21 CFR 120) 1
T FDA to Charge Industry for Food Safety - Increased Inspection Food Safety - ISO 22000, HACCP (21 CFR 120) 6
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 3

Similar threads

Top Bottom