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 can themselves 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. Today, the Wall Street Journal reported 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].

The study found that the three-year survival rate of 426 Medtronic leads inserted in the hospital’s patients was 90.8%, meaning 9.2% failed. In December 2009, one report estimated the failure rate of the Sprint Fidelis lead may eventually reach 30% of all patients.

Medtronic Heart Device Lawsuits

In lawsuits against Medtronic, patients represented by Lieff Cabraser have alleged that a design defect is responsible for their lead fractures. The complaints also allege that Medtronic failed to act timely as it knew of large numbers of failures of the device at least a year prior to issuing the recall. Learn more about the Medtronic heart lead recall.