March 25, 2009

Did Medtronic Know of Sprint Fidelis Lead Wire Problems in 2004?

About 150,000 people in the United States have been implanted with the Medtronic Sprint Fidelis leads. A previously undisclosed FDA report provided to New York Times Reporter Barry Meier indicates that soon after the Medtronic Sprint Fidelis lead was approved in late 2004, Medtronic received multiple reports that the device was fracturing.Within a year, the company had received 30 complaints about potentially fatal device fractures which prompted Medtronic to begin an internal investigation of the problem.  Because portions of the FDA report were redacted before its release, it is unclear what the company did between the time it became aware of safety problems until the lead wires were finally recalled in October of 2007 as a part of a Class 1 Recall.  The recall was issued following hundreds of reports from patients with defibrillators who were being shocked unnecessarily or having their heart device fail to deliver any shock when one was needed.   

Click here to view 3/14/09 New York Times article


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