Hospital Studies Find Medtronic Defibrillator Wires Fail at Higher Rates

February 2010

According to the reports of several top hospitals, Medtronic Inc.'s fracture-prone defibrillator wires are failing at a much higher rate than the company has publicly disclosed. The medical device company recalled the faulty Sprint Fidelis defibrillator wires in 2007 and replaced them with a different type of wire with a lower failure rate. However, approximately 150,000 Sprint Fidelis wires remain implanted in American patients.

Medtronic reported that Sprint Fidelis wires are effective for at least three years 95.4 percent of the time and only fail 4.6 percent of the time. Reports from hospitals tell a different story. Several medical centers, including the University of Rochester in New York state, the Minneapolis Heart Institute, the Mayo Clinic, and the University of Ottawa, said that the overall failure rate for the wires is as much as two times higher than what the company has claimed.

For example, the University of Rochester's hospital study found that the three-year survival rate for 426 Medtronic wires implanted in their patients was 90.8 percent, meaning that the failure rate was 9.2 percent. Medtronic said that their own data is more reliable, though, because it comes from a sample of many hospitals rather than just one facility.

Defibrillators are programmed to dispatch powerful lifesaving shocks to correct faulty heart rhythms in the event of cardiac arrest. When the wires fracture, the defibrillator can fail to send the needed jolt, and the patient can die. The defibrillator can also send repeated, massive jolts, which too can be fatal.

In March 2009, Medtronic said it had identified 13 deaths in which the Sprint Fidelis wire issues "may have been a possible or likely contributing factor." There are apparent links to at least 12 additional deaths identifiable in a Food and Drug Administration database, according to research by The Wall Street Journal.