Failure Rate for Medtronic Sprint Fidelis Leads on the Rise - By: Katie Kelley

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 260,000 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.

Defibrillator leads are medical devices found in implantable cardioverter defibrillators (ICDs) or a cardiac resynchronization therapy-defibrillators (CRT-Ds). 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. 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 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, 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.

About the Author

Visit LegalView.info for more information about Medtronic Defibrillator Leads or finding a potential mesothelioma lawyer if you or someone you know has been exposed to deadly asbestos at http://www.LegalView.info/.

Article Directory Source: http://www.articlerich.com/profile/Katie-Kelley/56723

Additional Articles From - Home | Reference & education | Legal