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FDA database that tracks medical device harms may miss red flags, safety experts warn
CBSN
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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As vaccination rates decline, widespread outbreaks of diseases like measles and polio could reemerge
Health officials in western Texas are trying to contain a measles outbreak among mostly school-aged children, with at least 15 confirmed cases. It's the latest outbreak of a disease that had been virtually eliminated in the U.S., and it comes as vaccination rates are declining — jeopardizing the country's herd immunity from widespread outbreaks.