Removing recalled Medtronic leads seen as difficult by most experienced surgeons.
The New York Times (4/7, B1, Meier) reports that Sprint Fidelis, which is a heart defibrillator cable, was pulled from the market by Medtronic after "five patients who had the cables died." However, "in the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart." So far, there have been four deaths due to damage done to blood vessels when less experienced doctors attempted to remove the leads. "Last year, to win approval for a new heart cable from the Food and Drug Administration, the company agreed to provide the F.D.A. with future data from '10 experienced extraction centers,' according to agency records." However, "Medtronic says it does not plan to make such a list public." Thus far, "Medtronic has been shielded...from legal claims over the recalled device" and "more than 1,000 patient lawsuits involving the Sprint Fidelis have been thrown out because of a ruling last year by the Supreme Court."