“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. This follows a report from December 2009 which estimated the failure rate of the Sprint Fidelis lead may eventually reach 30% of all patients.
On February 4, 2010, the Wall Street Journal noted that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device [login required].
