Patients Sue Medtronic Over Defective Lead Wires

-FDA News

10/24/2007- Two former users of Medtronic’s Sprint Fidelis Defibrillation Leads are suing the company over injuries from the device.

The patients are suing for their own damages and as representatives of a class of all users of the device, law firm Rheingold, Valet, Rheingold said. The suit was filed in federal court in Minnesota, the site of a previous suit against Medtronic for an earlier implantable cardiac defibrillator recall.

The plaintiffs allege that the lead wire portion of the defibrillator is defective due to cracks that develop in the wire. As a result, users of the device may receive jolting shocks when it falsely detects they need a jolt, or the devices may fail to provide defibrillation when needed.

Medtronic announced Oct. 15 that it is halting sales of the Sprint Fidelis line after five patient deaths in which a lead fracture may have been a possible or likely contributing factor. The company also is recommending against new implants of the leads. The FDA considers this a Class I recall.

Ennis & Ennis, P.A. is representing individuals that have been harmed defective medical devices such as the Medtronic defibrillator and pacemaker. If you or a loved one have suffered as a result of a defective Medtronic pacemaker or defibrillator or if you need more information about the Medtronic recall or class action lawsuit click here for a free, confidential case evaluation.