Defect in Heart Device Part Prompts Recall

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October 15th, 2007

"Faulty Electrical Lead in Heart Defibrillators"

A vital wire in certain implanted heart devices may falter and cause serious injury, possibly even death, according to an announcement made by the Food and Drug Administration on Monday. The defect has prompted the maker of the part to issue a voluntary recall.

Device Malfunction

The wire, commonly referred to as an electrical “lead,” connects the heart to implanted defibrillators, which treat abnormal heart rhythms. Properly functioning leads deliver a jolt of energy to the heart when it stops suddenly. Leads that malfunction, however, can deliver unnecessary jolts, or fail to deliver one when needed.

Medtronic , the maker of the Sprint Fidelis lead, issued the recall after discovering that some of the leads were prone to fracture, a problem which could cause the part to misread heart signals.

Patient Risk

Approximately 235,000 patients have been implanted with the devices, which have been used with Medtronic defibrillators since 2004. Medtronic estimates that the lead will fracture in about 4,000 to 5,000 patients in less than three years from the time of the implant.

Hundreds of patients have reported lead malfunctions, including inappropriate and painful shocks. As many as five deaths may be attributable to faulty leads.

Patients are urged to see their doctors to make sure the device is functioning properly.

Lead replacement surgery is risky, so the procedure is only recommended in patients whose device is improperly functioning.

(Source: New York Times online)

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