Sprint Fidelis Recall Spurs More Questions Than Answers

When the popular Medtronic Sprint Fidelis defibrillator was voluntarily withdrawn from the market, some industry officials praised the medical device maker for proactively removing a potentially dangerous product from the market. Two weeks later, Medtronic’s decision is coming under scrutiny. The Sprint Fidelis problem surfaced in January 2007 after pacemaker patients began complaining of multiple electrical shocks. Their cardiologists checked hospital records and notified Medtronic of the problem. On March 21, 2007 Medtronic sent a “Dear Doctor” letter stating that the company had received reports of fracture rates in the Sprint Fidelis 6949 and that a limited number of doctors had experienced fracture problems. The Medtronic letter intimated that the fractures were a result of improper procedure on the part of the doctors. However, some cardiologists disagreed with Medtronic’s insinuation. Notably, Dr. Robert G. Hauser, who had been instrumental in triggering the Guidant pacemaker recall, and Linda Kallinen, Minneapolis Heart Institute’s director, combed the data and found similar fractures in the leads of the Sprint Fidelis defibrillator.
It’s disturbing to note that Medtronic had known that the fractured lead wires had been linked to 5 deaths since August 2006 but failed to act until the situation became a crisis in October 2007.