Medtronic Sprint Fidelis Lead Failure Rates Reportedly As High As 9.2%

According to new research, the failure rate for recalled Medtronic Sprint Fidelis leads, which are small wires used to connect a defibrillator to the heart, could be twice as high as the manufacturer has claimed.

A number of prominent medical facilities, including the Mayo Clinic, the University of Rochester and the University of Ottawa, say that Medtronic’s published failure rate of 4.6% for the leads is wrong. According to a new study published in the January edition of the American Journal of Cardiology, the Medtronic Sprint Fidelis lead failure rate at three years was 9.2% at one particular hospital. In addition, researchers found that the failure rate of the leads is increasing as time goes by. 

A Medtronic Sprint Fidelis recall was issued on October 15, 2007, after it was confirmed that the small wires were prone to fracture or break. At the time of the recall, the leads were already implanted in about 268,000 people. If the defibrillator lead fails, it could result in a massive electrical shock or cause a patient’s cardiac defibrillator not to work when it is needed to deliver a life-saving jolt.

Researchers performed a retrospective review of 426 lead implants at the University of Rochester to highlight the hazards of the leads fracturing over time. They found that only 90.8% of the leads implanted survived after three years, and concluded that “the hazard of Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturer’s performance update.”

The researchers note that other defibrillator leads have shown no sign of increased failure rate over time, and say that more studies are needed to determine whether the fracture rate will continue to rise or level off over time.

The findings come after an analysis by UBS Investment Research in late December warned that Sprint Fidelis lead failures could reach as high as 30% over four years. The analysis also suggested that the leads appear more likely to fail in healthier patients.

Thousands of Medtronic defibrillator lead lawsuits have been filed on behalf of individuals who had the leads implanted, including hundreds who have had the lead fracture. However, most of those suits were dismissed last year due to a 2008 Supreme Court decision in Reigel vs. Medtronic, which was found to protect Medtronic from liability for their defective medical device because it was approved by the FDA.

While the Sprint Fidelis lawsuits are being appealed, efforts are underway in congress to overturn the Reigel Supreme Court decision with the Medical Device Safety Act of 2009. Senators last held a hearing on the bill in August, at which time the Government Accountability Office (GAO) released a report that determined that the FDA was inadequate to the task of being the sole insurer of medical device safety.