Class Action Status Requested To Benefit All Persons Who Reside in the United States and Were Implanted with Leads Manufactured by Medtronic, Inc.
Parker Waichman LLP, along with Smith & Nevares, Salas & Co. and Becnel Law Firm, LLC, announce that they have filed a lawsuit on behalf of a man who had to undergo a dangerous and life-threatening surgical procedure after a component of his Medtronic implantable defibrillator called a Sprint Fidelis lead fractured. The victim is bringing this action on his own behalf and as a representative of a class consisting of all persons who reside in the United States and were implanted with a lead manufactured by Medtronic, Inc., except those individuals whose Medtronic lead have malfunctioned. The suit was filed on behalf of the victim in the United States District Court for the District of Puerto Rico (Docket number: 07-1971).
If you or a loved one believes that you were injured as a result of a Sprint Fidelis lead used with a Medtronic implantable defibrillator, please contact our office by visiting www.yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).
The Sprint Fidelis lead is a wire that is used to attach a Medtronic implantable defibrillator to the heart. The Sprint Fidelis lead was first introduced by Medtronic in 2004, and has been used with most of the companyâ€™s implantable defibrillators since then. To date, Sprint Fidelis leads have been implanted in 235,000 patients. This component is used in cardiac defibrillators — or complex devices with defibrillation capacity — and not 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 â€œICDâ€). 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 â€œfrayedâ€ 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 notified physicians in March 2007 about the high fracture rate of the Sprint Fidelis lead.
In October 2007, Medtronic suspended sales of the Sprint Fidelis lead used in its implantable defibrillators after an analysis of the companyâ€™s data showed that the lead had a continuing fracture problem. This defect can cause the defibrillators to deliver a massive and painful electrical shock, or it can cause the device to fail to administer a lifesaving shock when necessary. According to Medtronicâ€™s own estimate, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. At least 5 patient deaths have been attributed to defective Sprint Fidelis leads.
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CONTACT: Parker Waichman LLP
David Krangle, Esq.