Medtronic Sprint Fidelis Lead Failures Could Hit 30% in Four Years

A new analysis by UBS Investment Research warns that the failure rate for Medtronic Sprint Fidelis defibrillator leads could reach as high as 30% over four years.

In its December 28 morning meeting highlights, UBS, the second largest manager of private wealth assets in the world, predicted that the problems with Medtronic’s Sprint Fidelis leads could have an industry-wide effect on medical devices. UBS analysts suggested that implant recalls would not only negatively impact the public’s perception of the risks vs. the rewards, but are also likely to lead to tougher regulatory requirements for the approval of medical devices.

A Medtronic Sprint Fidelis lead recall was issued on October 15, 2007, after it was confirmed that the small wires that connect defibrillators to the heart were prone to fracture or break. The leads were already implanted in about 268,000 people at the time they were pulled, and 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.

Although initial studies indicated that the leads had a failure rate of only about 3%, the UBS analysis predicts that rate could rise as high as 30% in patients over the next four years. The analysis also suggests that it appears that the leads are 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, those lawsuits 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.

Whether the bill passes or not, the UBS analysis indicates that investors should expect some changes at FDA in how the agency approves medical devices, largely due to the Sprint Fidelis lead recall. The leads were approved through a premarket notification process that only looks to see if a new device is substantially equivalent to an already legally approved device on the market, instead of through the more stringent premarket approval process (PMA).

“An increasing failure rate may help incite the FDA to lighten the PMA supplemental pathway,” the analysis determines.

Congress has intended for all high risk category Class III medical devices, like the Sprint Fidelis leads, to be approved through the PMA since 1976, but as of 2009, both the GAO and FDA agree that the agency is still far from meeting that goal.