Medtronic Defibrillator Leads Warning

October 2007

A special message for heart patients – your implanted defibrillator may have a defective wire that could provide a painful, unnecessary jolt of electricity to your heart or fail to deliver a life-saving jolt. Medtronic is warning patients that their Sprint Fidelis defibrillator leads have a serious defect that has caused lead fractures in hundreds of patients and may be linked to five deaths.

The problem stems from a defective electrical lead, a current-carrying wire, which connects the defibrillator to the heart. This faulty wire is in 268,000 patients worldwide. Sprint Fidelis lead fractures could affect thousands of defibrillator patients.

The following Sprint Fidelis models were available from September 2004 to October 2007:

This warning does not apply to every Medtronic defibrillator product, nor is it exclusive to Medtronic defibrillator users. Patients using any brand of defibrillator may be at risk to suffer painful and adverse effects if their doctor used the Sprint Fidelis lead to connect the defibrillator device to their heart.

Doctors may have used these leads in conjunction with an implantation surgery, or to replace another damaged or faulty defibrillator wire. Medtronic has advised all patients that received the lead to consult their doctors for corrective actions, monitoring, or advice.