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


Captain Nice
Staff member
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.

Ronen E

Problem Solver
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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.
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