October 15, 2010 – Medtronic has entered into a $268 million settlement relating to its Sprint Fidelis family of defibrillation leads.
The leads, which connect implantable electrophysiology devices to the heart, were pulled off the market in October 2007 due to a defect that caused a high rate of lead fractures. The cracked wires in some cases delivered unnecessary shocks or prevented a needed shock from reaching the heart. Lead failure was suspected in about 13 deaths. More than 250,000 Sprint Fidelis leads were implanted in patients prior to the 2007 recall.
Under the terms of the agreement, Medtronic is paying $268 million, which includes attorneys’ fees and administrative expenses. The parties will file joint requests to terminate the multidistrict litigation and Minnesota state court proceedings related to the Sprint Fidelis leads. It will also dismiss the plaintiffs’ appeals pending before the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals and will request dismissal of other Fidelis-related cases throughout the country. Medtronic can cancel the agreement if certain conditions are not met. The agreement can also be terminated by either party if the proceedings are not terminated.
For more information: www.medtronic.com