Failure Rate for Medtronic Sprint Fidelis Leads on the Rise

Medtronic Sprint Fidelis defibrillator leads could could reach a 30% failure rate over the next four years according to a new study published by UBS Investment Research.

Medtronic defibrillator leads were implanted in more than 260,000 patients world-wide before it was recalled due to safety concerns by its manufacturer in October 2007. Initial studies claimed the failure rate was only 3%, however recent studies point that the failure rate could increase dramatically as the devices age. For patients who do not have health insurance, replacing a malfunctioning defibrillator can be very expensive.

Medical devices, such as implantable cardioverter defibrillators (ICDs) or a cardiac resynchronization therapy-defibrillators (CRT-Ds) use defibrillator leads as a functioning part of the device. Similar to a pacemaker, ICDs and CRT-Ds are surgically implanted devices that monitor a patients heart rate and administer small electrical shocks to the heart in order to jolt it back to normal functioning. Although defects are generally rare, routine maintenance is required to ensure the lead is functioning properly, especially as the device ages.

The safety recall was issued in 2007 after a study found the Sprint Fidelis defibrillator leads were prone to breaking inside the patients' body at an alarmingly high rate. A malfunctioning lead can cause unnecessary electric shocks, or worse, cardiac arrest when the device fails to regulate the heart beat properly.

A number of Medtronic Defibrillator Lead Lawsuits were filed on behalf of individuals who have had the leads implanted, however in 2008, the Supreme Court ruled in Reigel vs. Medtronic that Medtronic is free from liability for the faulty devices since the Medtronic Defibrillator Leads were approved by the U.S. Food and Drug Administration (FDA).

Although many patients are appealing the Supreme Court decision, many patients are still left with the financial burden of replacing a defective device. The United States Congress has proposed the Medical Device Safety Act of 2009 as an attempt to overturn the Supreme Court decision.

Furthermore, the FDA has been under scrutiny by the Government Accountability Office (GAO) who has found the FDA approval process is not sufficient enough to insure medical device safety. Many medical devices, including the Medtronic Defibrillator Lead underwent a premarket notification process, which determined whether the device was the same as other devices currently legally approved rather than a more stringent premarket approval process that looked at the qualities of the individual device by itself. Federal law requires that all high risk Class III medical devices, including implantable devices such as defibrillator leads, undergo a PMA process, however both the GAO and FDA agree that the FDA is far from meeting the goal.