Medtronic has acknowledged that 13 people may have died in connection with the Sprint Fidelis lead.
Sprint Fidelis Defibrillator leads were approved by the FDA in 2004 and manufactured for a little over 3 years, from September of that year to October 2007. In early 2007, it was reported that the leads might have been fracturing at a higher rate than Medtronic's other leads. This eventually lead to a recall.
The New York Times reports that about 150,000 in this country still have the Sprint Fidelis lead. This number includes members of our local ICD group.
A fractured lead can cause a patient's death if it precludes the ICD from detecting a dangerous arrhythmia, thus preventing it from delivering a lifesaving shock. It can also cause the ICD to fire for no reason, delivering an unnecessary shock.
Full NY Times article here.