Sprint Fidelis Wire Defibrillator Lead Failure

Recall Has Patients Wondering Whether to Have Wire Leads Removed

Following a October 2007 recall on the Sprint Fidelis electronic defibrillator leads, some patients are opting to have lead wires replaced.

Problems with Medtronic's Sprint Fidelis defibrillator wires were first brought to light in a March 2007 Dear Doctor Letter advising that the wire leads were prone to fracture. Reports of patient deaths and inappropriate patient shocks prompted the US FDA to issue a Class 1 Recall on the wire leads in October 2007.

There are still thousands of patients who have Medtronic's Sprint Fidelis leads left wondering if they should leave the wire lead in place and hope it does not fail or whether to have it extracted, sometimes at their own expense. Medtronic is limiting its contribution to wire lead removals to $800.00 for a procedure that can cost $12,500.00, and insurance companies appear to be dealing with coverage on a case-by-case basis.

The lead is a thin plastic tube enclosing electrical wires and sensors. The risks associated with surgical removal, besides the possibility for infection, include potential perforation of the heart and the veins in the chest. There is also a slight danger of damaging the heart valve through which the lead is threaded.