Parker Waichman Alonso LLP, Along with Smith & Nevares, Salas & Co. ... (in conventional pacemakers. Some patient...)

Parker Waichman Alonso LLP, Along with Smith & Nevares, Salas & Co. and Becnel

Date:10/17/2007

in conventional pacemakers. Some patients with congestive heart failure use devices that include this defibrillation ability, and those are among the machines that use the Sprint Fidelis lead.

According to the lawsuit, the victim, a resident of Kentucky, received a cardiac pacemaker/defibrillator combination (an "ICD"). The ICD was attached to his heart with a Sprint Fidelis lead wire system manufactured by Medtronic on March 25, 2005. On June 22, 2006, the lead had to be surgically removed in an emergency procedure after it was found to be "frayed" in the nature of a fracture.

Those patients whose Sprint Fidelis lead fractures must undergo a dangerous surgical procedure to have the wire replaced. The procedure could cause tearing and scarring of the heart and veins through which the Sprint Fidelis lead wire runs. The surgery to replace a defibrillator lead wire is far riskier than having the device itself replaced.

Defibrillator leads are one of the devices most fragile components. Since the Sprint Fidelis lead was introduced to the market in 2004 it has become evident that a significant portion of the leads have potentially fatal defects. Such defects were discussed in an article written by doctors at The Minneapolis Heart Institute, one of the premier heart institutes in the world, based on a study of the incidence of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models. Researchers at The Minneapolis Heart Institute found that, between September 2004 and February 2007, 583 patients were implanted with Sprint Fidelis Model 6949 leads and nine patients received other Sprint Fidelis models. During that time, six patients experienced Sprint Fidelis Model 6949 lead failures. The failed Sprint Fidelis Model 6949 leads had been implanted by various electrophysiologists, cardiologists and thoracic surgeons. The average time to failure was fourteen months (based on a range of four to twenty-three months). Medtronic first noti
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Parker Waichman Alonso LLP, Along with Smith & Nevares, Salas & Co. ...(in conventional pacemakers. Some patient...),Health