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

Marc

Fully vaccinated are you?
Leader
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
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
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 6
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
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
V FDA 510K - Pre Submission Query US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
T Link GMDN code and FDA product code US Medical Device Regulations 5
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7
Ed Panek Consultant Request SaMD AI "Expert" FDA US Food and Drug Administration (FDA) 2
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
shimonv FDA-recognized Standards US Food and Drug Administration (FDA) 0
R FDA ECG Data Requirements Medical Information Technology, Medical Software and Health Informatics 3
L Language of quality system in case of FDA inspection US Food and Drug Administration (FDA) 1
M Can you import medical device not FDA approved into the USA under an IND application? US Food and Drug Administration (FDA) 2
Ed Panek FDA Submits to White House Plan to Harmonize with ISO 13485 US Medical Device Regulations 2
Melissa Contract Mfg--to Manufacturer with the FDA ISO 13485:2016 - Medical Device Quality Management Systems 4
Ed Panek ANNUAL FDA Registration - What 510(k) number to use? US Food and Drug Administration (FDA) 1
Y FDA vs (EU) 2021/2226 Electronic Instructions for Use (eIFUs) US Medical Device Regulations 1
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
C FDA logo for marketing US Food and Drug Administration (FDA) 3
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5
M FDA Syringe Marking requirements US Food and Drug Administration (FDA) 4
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B When FDA Decision Summary opens? US Food and Drug Administration (FDA) 4
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12

Similar threads

Top Bottom