October 15, 2007: Warning on Faulty Defibrillator Component
Medtronic Inc, the manufacturer of defibrillator, informed and healthcare professionals that there was an electrical wire called “lead” that connects the defibrillator to the heart could crack. Medtronic has announced that it has voluntarily postponed all the distribution of the “Sprint Fidelis” leads. Medtronic defibrillators included Fidelis lead since 2004. Medtronic Inc issued a press release that stated that there was an approximated 268,000 patients with implanted Sprint Fidelis leads might experience lead cracks as “audible alerts, inappropriate shocks and/or loss of output.” and the manufacturer identified five deaths where Sprint Fidelis lead crack might have been the contributing factor. Medtronic was not replacing the leads because of the risks of implanting a different lead are greater compared to the risks from the fracture of the Sprint Fidelis lead.
November 28, 2006: Court Denies Request to Dismiss Medtronic Suits
Medtronic Inc declared that the Minnesota District Court denied its appeal to dismiss numerous defective products cases over its recalled implantable heart defibrillators. Medtronic claimed that the regulations of US Food and Drug Administration and its approval of the defibrillators should stop the lawsuits. Even though Medtronic was planning to appeal the decision of the court, the denial of the manufacturer’s request for dismissal could result to “out-of-court” settlement of some claims.
August 18, 2006: Medtronic Sued Over Faulty Pacemaker
A resident from West Virginia filed a lawsuit against Medtronic Inc claiming that the battery that gave power to his pacemaker could fail anytime, a probability that the manufacturer acknowledged in 2005. The plaintiff had the Marquis DR ICD Model 7274 which was implanted to him in 2002 and was told that the battery would last for about 25 years.
February 11, 2005: Medtronic Issues Notification on Certain Defibrillators
The US Food and Drug Administration announced that Medtronic issued a notification about certain implantable defibrillators models. Medtronic, the manufacturer, voluntarily advised doctors regarding the battery shorting mechanism that may happen in a subset of implantable cardoverter-defibrillator or ICD and cardiac resynchronization therapy defibrillator or CRT-D models.