A new study published by UBS Investment Research shows that an estimated 30% of Medtronic Sprint Fidelis defibrillator leads could fail over the next four years.
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. The financial burden to replace a malfunctioning defibrillator can be very expensive, especially for patients who may not have health insurance.
Medtronic Defibrillator Leads are medical devices found in implantable cardioverter defibrillators (ICDs) or a cardiac resynchronization therapy-defibrillators (CRT-Ds). ICDs and CRT-Ds are implanted in patients with a heart arrhythmia to monitor heart rate and administer a small electrical shock if need be to jolt the heart back to normal functioning. Because the devices are normally surgically implanted, routine maintenance is often required to ensure the lead is working properly, especially as the device ages, however defects for the device are generally rare.
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).
Despite the number of appeals, many patients have been left with a significant financial burden because of the device. The United States Congress is attempting to overturn the Supreme Court decision with the Medical Device Safety Act of 2009.
Additionally, the Government Accountability Office (GAO) issued a report that determined the FDA approval process is not adequate enough to insure the medical device safety. The Medtronic Defibrillator Lead was subjected to a premarket notification process, which determines if the new device is equivalent to an existing roduct on the market rather than a more stringent premarket approval process (PMA). A PMA is legally required for all high risk Class III medical devices, such as defibrillator leads, however, but the FDA and the GAO agree the FDA is far from meeting such a goal.
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