this post was submitted on 19 Dec 2023
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FDA database that tracks heart device harms may miss red flags, safety experts warn (www.cbsnews.com)
submitted 10 months ago by MicroWave@lemmy.world to c/health@lemmy.world
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Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost certainly die within a year.

The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 — currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.

The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMate 3 prevented the device from sealing, causing multiple strokes and leading to a severe brain injury and multiorgan failure. Herrman "could not have anticipated the danger this defect … created for him," the lawsuit said.

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[–] plain_and_simply@feddit.uk 2 points 10 months ago

This is beyond tragic.

[–] Gork@lemm.ee 2 points 10 months ago

This wouldn't be the first time that an FDA database that tracks device safety failed in its intended purpose.