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Failure Rate For Medtronic Sprint Fidelis Leads On The Rise
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.
Medtronic defibrillator leads were implanted in more than 260,[link widoczny dla zalogowanych], 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.
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. 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).
Despite the number of appeals, many patients have been left with a significant financial burden because of the device. The United States Congress has proposed the Medical Device Safety Act of 2009 as an attempt to overturn the Supreme Court decision.
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. Many medical devices,[link widoczny dla zalogowanych], 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. A PMA is legally required for all high risk Class III medical devices,[link widoczny dla zalogowanych], such as defibrillator leads, however,[link widoczny dla zalogowanych], but the FDA and the GAO agree the FDA is far from meeting such a goal.
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