The Wall Street Journal (2/24, Burton) reports that Medtronic Inc.’s Sprint Fidelis defibrillator leads, “pulled from the market in 2007, represent an ‘increasing hazard’ for more than 200,000 heart patients world-wide,” according to “Minneapolis Heart Institute cardiologist Robert G. Hauser, who first spotted the fractures in the Sprint Fidelis leads in early 2007, and David L. Hayes, chairman of cardiology at the Mayo Clinic in Rochester, Minn.” The cardiologists say that the “potential danger from fractures and other failures increases as the implanted wires…age.” The Journal adds, “It is estimated that about 150,000 Sprint Fidelis leads remain implanted in U.S. patients.”
The New York Times (2/24, B9, Meier) reports that in a study published online in the journal HeartRhythm, “Dr. Hauser and Dr. Hayes reviewed the performance of all defibrillator leads implanted at their institutions from 2004 to 2008. Of about 3,000 leads implanted during that period, the Sprint Fidelis accounted for 848 leads, or about 28 percent of the total.” According to the investigators, “during the period, the annual failure rate of the Sprint Fidelis was 3.75 percent compared with 0.6 percent for other leads.” The researchers also found “that the failure rate was increasing.” The physicians wrote, “The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable.” The Times adds that “Medtronic and heart experts said leads that are functioning should not be removed as a precaution, because of the risks involved in the removal procedure.”
From the American Association for Justice news release.