Back in May 2019 arstechnica.com reported on a little-known reporting avenue which the FDA was allowing some companies to use to report failures of their devices. This reporting avenue was in addition to the normal publicly available one and completely hidden from the public. The device in the quote below sounds like a pacemaker-kind of thing.
Link 1
Quote:
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.
Medtronic recalled the device in 2007 but only after it was implanted in around 268,000 patients. Many of those patients have since faced the ghastly choice of learning to live with the faulty device or undergoing an invasive, risky—sometimes deadly—surgery to remove it. According to the KHN investigation, they’ve been making that choice without information from the 50,000 incident reports.
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I think this is scary.
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