Medtronic Recalls Defective Sprint Fidelis Leads
On October 14, 2007, Medtronic, the nation's largest heart implant device manufacturer, announced a defect in the critical electrical "lead" component of its heart defibrillator. The New York Times reported on October 15, 2007, that the defect in this electrical wire, called the Sprint Fidelis, has resulted in hundreds of malfunctions and may have played a role in the death of five Medtronic defibrillator patients.
In a news release published by Medtronic, the company says that since the Sprint Fidelis lead was introduced in 2004, approximately 268,000 patients in the United States have been implanted with the lead as part of the Medtronic defibrillator. Affected models of the Sprint Fidelis defibrillation leads are 6930, 6931, 6948 and 6949. All patients who have received the Medtronic defibrillator since 2004 are urged to visit their doctor to check for potential fractures. A fracture in the lead can cause the device to misread heart rhythms, sending unnecessary, painful shocks to patients or worse, failing to provide a vital life-saving shock.
The New York Times reports:
Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. Those patients will require a delicate surgical procedure to replace the lead, experts said.Medtronic said it would stop selling the lead and recall all leads not yet implanted.
Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients were better off leaving the lead in place except in those instances where it has stopped functioning properly.
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