A Medical Device Daily

Just days after Medtronic (Minneapolis) said it would stop selling its Sprint Fidelis defibrillation leads, former users of the device have already begun to files lawsuits against the med-tech giant for injuries they claimed were sustained through its use (Medical Device Daily, Oct. 16, 2007).

Leonard Stavish and Kelly Liusi, allege in a complaint that the lead wire portion of the defibrillator was defective, because of cracks that develop in the wire. A lawsuit is also being filed on behalf of three patients who reside in Puerto Rico.

As a result of the cracks in the lead wires, patients implanted with the device either received jolting shocks when it falsely detected that the user needed a jolt from the device, or that the device failed, so that when they actually needed defibrillation they could not get it. The lead is a wire that runs from the device, which is implanted in the chest, down through an artery in the heart.

The Sprint Fidelis wires are suppose to deliver electrical jolts from stopwatch-sized defibrillators implanted in the chest to regulate faltering heartbeats. The devices are used in people at risk of cardiac arrest, the biggest killer in the U.S.

Plaintiffs in the cases are suing for their own damages and as representatives of a class of all users of the device. Suit was filed in the federal court in Minnesota, site of a previous mega suit against Medtronic for an earlier implantable cardiac defibrillator recall. Patients claim they received as many as 47 dangerous jolts even though their heart was not calling for help. The Minneapolis lawsuit seeks a court order requiring the company to pay for diagnostic and corrective treatment and monitoring for as many as 100,000 patients who have the devices. The suits allege that Medtronic was aware of the fault in the lead of the Sprint Fidelis, which came on the market in 2004, but did not issue warnings, and that the lead was defectively designed. It is also alleged that the device violated consumer protection laws in the states where the plaintiffs reside.

The FDA said it first notified physicians in March about the fracture rate and the proper method for implantation. Both Medtronic and the agency are recommending against surgical removal of the leads, saying that the risk of replacing the device exceeds the risk of a lead fracture.

The FDA approved the Fidelis defibrillation leads in September 2004 (MDD, Sept. 3, 2004).

“I believe that this new Medtronic litigation will follow the pattern of the previous litigation. It is unfortunate that Medtronic did not learn a lesson from it and stop sales much earlier than it did. The medical community published reports about this defect and Medtronic refused to act on it,” said Hunter Shkolnik, who is representing several plaintiffs in the case.