FDA Announces Class 1 Recall of Medtronic Sprint Fidelis® Defibrillator Leads

On October 17, 2007, the FDA issued a Class 1 recall of Medtronic’s Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949, manufactured from September 2004 through October 15, 2007. Defibrillator leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to a patient’s heart. ICDs and CRT-Ds are devices that monitor heart rhythms, and deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices are surgically implanted into patients who are at risk of sudden cardiac arrest.

The Medtronic leads are being recalled because of a risk of fracture. If a lead fractures, it can have serious consequences: some patients can receive unnecessary and massive shocks, sometimes compared to the jolt of sticking a fork in a light socket. Other patients don’t get the shock when they do need it to save their lives after cardiac arrest. Overall, five patients so far have died in cases Medtronic says may be related to the flaw.

Consumers with implanted defibrillators are urged to contact their cardiologists immediately. A list of commonly asked questions and responses prepared by the FDA concerning the recall can be accessed here.

A post on the Drug Industry Watch blog by Tom Lamb observes that warning signals about flaws in Medronic’s leads surfaced as far back as March 2007 when Medtronic sent a "Dear Doctor" letter to cardiologists. Lamb questions whether the FDA moved quickly enough to issue a recall.

Lamb references a helpful article in the Wall Street Journal article outlining patient options in connection with the recall.