The Medtronic Heart Lead Recall
In October 2007, Medtronic issued a recall of its Sprint Fidelis heart lead. The device is a thin electrical cable that connects an implanted defibrillator to a patient's heart which were implanted in over 200,000 patients.
When the Sprint Fidelis leads fracture, the defibrillator can fail to send a needed electrical jolt, and the patient can die. Or the defibrillator can send repeated, massive shocks, which themselves can be fatal.
In March 2009, Medtronic disclosed that at least 13 Sprint Fidelis patients may have died, including four patients whose deaths were related to efforts by doctors to surgically remove the product. In February 2010, the Wall Street Journal reported [login required] that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device.
"The hazard of [Sprint] Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturer's performance update," doctors at the University of Rochester concluded in findings published in the January 2010 issue of the American Journal of Cardiology [abstract only].
Medtronic Announces Settlement
On October 14, 2010, Medtronic announced that it has entered into an agreement to settle the litigation, subject to certain conditions.
One day later, the Eighth Circuit U.S. Court of Appeals issued an opinion dismissing the injury lawsuits against Medtronic on the basis that a federal statute granted the corporation immunity from claims based on injuries due to its heart lead.
As of January 2013, the majority of claims had been paid through the Settlement Administration Process.