October 15, 2007: Warning on Faulty Defibrillator Component
Defibrillator manufacturer Medtronic Inc. warned patients and health care providers that an electrical wire (called a "lead") that links the defibrillator to the heart could fracture. Medtronic announced that it is voluntarily suspending all distribution of the "Sprint Fidelis" leads. Medtronic defibrillators have included the Fidelis lead since 2004. According to a Press Release from Medtronic, Inc., the estimated 268,000 patients who have been implanted with Sprint Fidelis leads might experience lead fractures as "audible alerts, inappropriate shocks and/or loss of output," and the company has identified five deaths "in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor." Medtronic is not recommending replacement of the leads, because risks posed by implanting of a different lead are greater than risks presented by fracture of the Sprint Fidelis lead.
November 28, 2006: Court Denies Request to Dismiss Medtronic Suits
Medtronic, Inc. announced that a Minnesota District Court has denied its request to dismiss numerous defective product lawsuits over the company's recalled implantable heart defibrillators. Medtronic has argued that U.S. Food and Drug Administration (FDA) regulations (and the FDA's approval of the defibrillators) should preempt the lawsuits. Although Medtronic plans to appeal the decision, the court's denial of the company's request for dismissal could lead to out-of-court settlement of some claims.
August 18, 2006: Medtronic Sued Over Faulty Pacemaker
A West Virginiaresident filed suit against Medtronic, Inc. alleging that the battery poweringhis pacemaker could fail at anytime, a possibility that the company acknowledgedin 2005. The plaintiff had the Marquis DR ICD Model 7274 implanted in 2002, andwas told that the battery would last for 25 years.
February 11, 2005:Medtronic Issues Notification on Certain Defibrillators
The U.S. Food and Drug Administration (FDA) announced thatMedtronic has issued a notification regarding certain implantable defibrillatormodels. Medtronic voluntarily advised physicians about a potential batteryshorting mechanism that may occur in a subset of implantablecardioverter-defibrillator (ICD) and cardiac resynchronization therapydefibrillator (CRT-D) models. Click here toread more from the FDA.
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