FDAnews Device Daily Bulletin

Two former users of the Sprint Fidelis Cardiac Leads made by Medtronic filed suit for injuries sustained through the implantation of this device, law firm Rheingold, Valet, Rheingold said.

The patients are suing for their own damages and as representatives of a class of all users of the device, it added. The suit was filed in the 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 was defective, due to cracks that develop in the wire. As a result, some users of the device received jolting shocks when it falsely detected that the user needed a jolt, or the device failed, not providing defibrillation when actually needed.

Medtronic is suspending all sales of its Sprint Fidelis line.