Red Lake Nation News - Babaamaajimowinan (Telling of news in different places)

FDA hidden database included 37,000 reports of problems with Medtronic defibrillator wires


When medical device maker Medtronic pulled its popular but fracture-prone Sprint Fidelis defibrillator leads from the market a decade ago, a cascade of complaints involving tens of thousands of the skinny wire devices soon followed.

The leads, which allow an implanted defibrillator to shock the heart and prevent sudden cardiac death, were the subject of more than 36,900 individual reports of problems, ranging from delivery of unneeded shocks (2,898 reports) to fractures in the wires (22,093). But those reports were not known to the public, until this week.


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