Medtronic said Thursday it has agreed to pay $268 million to settle U.S. lawsuits and claims related to its Sprint Fidelis family of defibrillation leads which it recalled three years ago.
The leads are wires that connect implantable devices to the heart, and allow the devices to send an electric shock to the heart when it is not beating properly. Medtronic took the wires off the market in October 2007 because of a defect that made some of the wires crack. The cracks can deliver unnecessary shocks or prevent a needed shock from reaching the heart.
In 2009, the company estimated that at least 13 people may have died because of the problem. More than 250,000 Sprint Fidelis leads were implanted in patients before the recalls. Some patients needed new surgery to remove the wires, although Medtronic and heart experts said most patients should not have the leads removed because of the risks involved in the procedure.
The company will record the settlement as a special charge in its fiscal second quarter.
Medtronic, the world's largest medical device maker, said the payment includes attorneys' fees and administrative costs. The company and the plaintiffs will file requests to dismiss plaintiffs' appeals that are pending in the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals.
Medtronic Inc. said the parties also will seek to dismiss Fidelis-related cases nationwide.