| Medtronic Sprint Fidelis defibrillator leads could could | | | | when the device fails to regulate the heart beat |
| reach a 30% failure rate over the next four years | | | | properly. |
| according to a new study published by UBS | | | | A number of Medtronic Defibrillator Lead Lawsuits |
| Investment Research. | | | | were filed on behalf of individuals who have had the |
| Medtronic defibrillator leads were implanted in more | | | | leads implanted, however in 2008, the Supreme Court |
| than 260,000 patients world-wide before it was | | | | ruled in Reigel vs. Medtronic that Medtronic is free |
| recalled due to safety concerns by its manufacturer | | | | from liability for the faulty devices since the |
| in October 2007. Initial studies claimed the failure rate | | | | Medtronic Defibrillator Leads were approved by the |
| was only 3%, however recent studies point that the | | | | U.S. Food and Drug Administration (FDA). |
| failure rate could increase dramatically as the devices | | | | Although many patients are appealing the Supreme |
| age. For patients who do not have health insurance, | | | | Court decision, many patients are still left with the |
| replacing a malfunctioning defibrillator can be very | | | | financial burden of replacing a defective device. The |
| expensive. | | | | United States Congress has proposed the Medical |
| Medical devices, such as implantable cardioverter | | | | Device Safety Act of 2009 as an attempt to |
| defibrillators (ICDs) or a cardiac resynchronization | | | | overturn the Supreme Court decision. |
| therapy-defibrillators (CRT-Ds) use defibrillator leads | | | | Furthermore, the FDA has been under scrutiny by |
| as a functioning part of the device. Similar to a | | | | the Government Accountability Office (GAO) who |
| pacemaker, ICDs and CRT-Ds are surgically implanted | | | | has found the FDA approval process is not sufficient |
| devices that monitor a patients heart rate and | | | | enough to insure medical device safety. The |
| administer small electrical shocks to the heart in order | | | | Medtronic Defibrillator Lead was subjected to a |
| to jolt it back to normal functioning. Although defects | | | | premarket notification process, which determines if |
| are generally rare, routine maintenance is required to | | | | the new device is equivalent to an existing roduct on |
| ensure the lead is functioning properly, especially as | | | | the market rather than a more stringent premarket |
| the device ages. | | | | approval process (PMA). Federal law requires that all |
| The safety recall was issued in 2007 after a study | | | | high risk Class III medical devices, including implantable |
| found the Sprint Fidelis defibrillator leads were prone | | | | devices such as defibrillator leads, undergo a PMA |
| to breaking inside the patients' body at an alarmingly | | | | process, however both the GAO and FDA agree that |
| high rate. A malfunctioning lead can cause | | | | the FDA is far from meeting the goal. |
| unnecessary electric shocks, or worse, cardiac arrest | | | | |