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ICD Lead Recall Frightens Patients and Physicians Alike

Medtronic’s Sprint Fidelis ICD lead has been recalled because of concerns about its long-term performance.

On October 15, 2007, Medtronic announced an immediate recall of its Sprint Fidelis defibrillation lead for implantable cardioverter-defibrillator systems. In a notice to physicians, a company representative stated that Fidelis leads should no longer be implanted and that the remaining unimplanted products should be removed from circulation. The Fidelis lead became commercially available in September 2004 and was an immediate hit because of its small diameter. It soon became Medtronic’s best-selling ICD lead: To date, more than 268,000 have been implanted.

By March 2007, lead failures were being reported — not at a higher rate than other leads but at a location not normally implicated: the distal portion of the lead. At that time, Medtronic attributed the unusual fracture location to implant technique. Another 6 months of intensive follow-up have demonstrated a drop-off in lead performance and a malfunction rate that may be higher than that of Medtronic’s previous-generation lead (by one reckoning, as high as 2.3% at 2.5 years of follow-up). At present, the variations are not statistically significant, but mounting concern has led to this recall.

Patients with implanted Fidelis leads are instructed to consult their physicians. Medtronic has advised physicians to program the ICDs to warn patients with a beeping sound if the lead is failing. When patients hear the warning, they are to contact their physicians. Neither Medtronic, its Independent Physician Quality Panel, nor the FDA is recommending removal of the Fidelis leads at this time.

Comment: The Medtronic lead has been one of the most frequently implanted ICD leads over the last 2.5 years. Although the lead’s performance is not statistically inferior to that of previous leads, there is cause for concern because of the unusual location of the lead fractures and the possibility that the fracture rate will increase with time. The next 6 months of follow-up will be critical in determining the long-term durability of the lead. For now, programming the ICD to be more sensitive — and to alert the patient and physician — to lead malfunction is a rational course of action.

— Mark S. Link, MD

Published in Journal Watch Cardiology October 24, 2007