Medtronic Sprint Fidelis Defibrillator Leads may be defective and create risk of serious injury.

Ongoing investigation and potential action relating to potentially defective Medtronic Sprint Fidelis Defibrillator Leads.

The Sprint Fidelis Lead is a wire that is used to attach a Medtronic implantable defibrillator to the heart. The Sprint Fidelis Lead was first introduced by Medtronic in 2004, and has been used with most of the company’s implantable defibrillators since then. This component is used in cardiac defibrillators -- or complex devices with defibrillation capacity -- and not in conventional pacemakers. Some patients with congestive heart failure use devices that include this defibrillation ability, and those are among the machines that use the Sprint Fidelis Lead.

Medtronic’s Sprint Fidelis Leads have been shown to have a continuing fracture problem. This defect can cause the defibrillators to deliver a massive and painful electrical shock, or it can cause the device to fail to administer a lifesaving shock when necessary. Such defects were discussed in an article written by doctors at The Minneapolis Heart Institute, one of the premier heart institutes in the world. The researchers at the Minneapolis Heart Institute compared data regarding lead failures in both the Sprint Fidelis models and Medtronic’s earlier Sprint Quattro models. The study found the thinner Sprint Fidelis Lead had a higher chance of fracturing than the Sprint Quattro. According to Medtronic’s own estimate, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis Lead will experience fracture within 30 months of having a defibrillator implanted.

When a Sprint Fidelis Lead fractures, a patient must undergo a surgical procedure that can tear and scar the heart tissue and veins through which the Sprint Fidelis Lead wire runs. The surgery to replace a defibrillator lead wire is far riskier than having the device itself replaced.

The Sprint Fidelis Leads have been implanted into hundreds of thousands of people, leaving all of them at risk for serious injury if a Sprint Fidelis Lead fractures. Medtronic suspended sales and recalled all unused Sprint Fidelis Leads on October 15, 2007 after receiving reports of at least 5 fatalities linked to lead fractures.