Saturday, March 14, 2009

Sprint Fidelis Leads Linked to 13 Deaths

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.

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