NEW YORK, Oct. 16, 2007 (PRIME NEWSWIRE) -- Parker Waichman Alonso 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 have a Sprint Fidelis lead emergently replaced as a result of a fracture. The fracture of the Sprint Fidelis lead required that the man undergo a surgical procedure known to have the potential for serious and life-threatening complications. 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. (NYSE:MDT), except those individuals whose Medtronic leads 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).
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.
The Sprint Fidelis lead is a wire that is used to attach a Medtronic implantable defibrillator to the heart. Most Medtronic defibrillators implanted since 2004 use the Sprint Fidelis lead. 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.
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 company'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 Medtronic'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. Those patients whose Sprint Fidelis lead fractures must undergo a dangerous surgical procedure to have the wire replaced.
About Parker Waichman Alonso LLP:
Parker Waichman Alonso LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective products, medications and medical devices.
For more information on Parker Waichman Alonso LLP, please visit: www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
More information on this and other class actions can be found on the Class Action Newsline at www.primenewswire.com/ca.