On behalf of Californians implanted with Sprint Fidelis leads, counsel for Rasheed Hunter announced the filing of a class action lawsuit. The leads are the wiring connecting an implanted defibrillator to the heart. Medtronic suspended use of the product on October 15, 2007 after 5 patient deaths were associated with the failure of the leads.
In the lawsuit, Mr. Hunter seeks to hold Medtronic responsible for all diagnostic and medical charges as well as possible (corrective) surgical expenses caused by the faulty devices.
Medtronic believes that the risk is small. From their letter to patients: “Patients with a Sprint Fidelis lead are more likely to experience complications from removal than from a problem with a Sprint Fidelis lead.” They go on to suggest that reprogramming might serve to further mitigate the problem in their letter to physicians.
According to the Medtronics website, there have been over 268,000 Sprint Fidelis leads implanted to connect the life saving defibrillators to patients’ hearts.
Sadly this is truly a no win situation for everyone involved. Medtronic acknowledges the small failure rate and the deaths linked to it. They further acknowledge that they concur with the opinion of the Independent Physician Quality Panel which believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances.