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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Defibrillator Recalls

Sprint Fidelis, a popular heart defibrillator model has been recalled due to a defect that may have contributed to five deaths.

The defect is an electrical wire in the Sprint Fidelis, manufactured by Medtronic, which can cause the device to deliver unnecessary electric shocks to the heart or fail to shock when needed. Medtronic estimates 4,000 to 5,000 people will experience a problem with the wire during the first 30 months of use.

Medtronic urges 235,000 patients with the lead, known as the Sprint Fidelis to see their doctors to ensure there is not a fracture in the lead that can make the device misread heart-rhythm data. In most cases, the defibrillators can be reprogrammed without surgery to correct the problem.

The recall Includes: Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured by Medtronic, from September 2004 through October 15, 2007.

Medtronic has halted selling leads and recalled all leads not yet implanted.

Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients were better off leaving the lead in place except in those instances where it has stopped functioning properly.

The Fidelis lead has been used with Medtronic defibrillators since 2004, and most patients who received Medtronic defibrillators since then have them. Patients who have recently had defibrillators replaced because their batteries were running down may not have the leads because doctors commonly attach replacement defibrillators to the existing leads when possible.