|
Patients file Medtronic defibrillator lawsuit |
|
Tuesday, 16 October 2007 |
Two patients who allege they were injured by faulty lead wires in their defibrillators have filed a lawsuit against their manufacturer, Medtronic Inc. Leonard Stavish and Kelly Luisi claim that defects in their Sprint Fidelis leads—the metal wires that connect a defibrillator to the heart—caused their defibrillators to deliver painful, unnecessary shocks to their hearts. The lawsuit is seeking class action status on behalf of patients who were injured due to defibrillator wire problems.
Medtronic recalled the Sprint Fidelis leads on October 14 due to an increased risk that they could fracture, causing the defibrillators to malfunction. Fractured lead wires could cause the devices to failure to deliver a life-saving jolt to a patient’s heart, or could cause them to deliver a series of painful shocks. The Food and Drug Administration says that at least 599 patients have been injured due to problems with Medtronic leads, including at least 204 whose defibrillators delivered unnecessary shocks.
Stavish says that his defibrillator delivered 47 painful shocks to his heart as a result of a fracture in the Sprint Fidelis leads attached to his heart. As a result, he needed to have his defibrillator and the lead wires replaced by a surgeon. Replacing the defibrillators lead wires attached to the heart can be dangerous because it can tear at scar tissue in the heart.
The Medtronic lawsuit also alleges that Luisi was hospitalized after her Medtronic defibrillator delivered a series of painful shocks because of defibrillator wire problems. Like Stavish, she was also forced to have her Sprint Fidelis leads removed.
The defibrillator recall lawyer for Stavish and Luisi says that he expects to file at least 25 additional Medtronic defibrillator lawsuits on behalf of clients who were injured because of problems with Sprint Fidelis leads. Financial experts have indicated that because more than 250,000 people have been implanted with the lead wires, Medtronic could be facing even more lawsuits than the 1,000 that were filed over the company’s 2005 defibrillator recall. |