Medtronic reported that it has voluntarily suspended worldwide distribution of its Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends discontinuing the use of its leads (Sprint Fidelis models: 6930, 6931, 6948 and 6949).
The Sprint Fidelis leads are used to deliver therapy in defibrillators, including implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Approximately 268,000 Sprint Fidelis leads have been implanted worldwide, and the Minneapolis-based Medtronic said the current decision does not affect its pacemaker patients.
According to a Medtronic release, the decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action.
Based on Medtronic’s extensive performance data, its Sprint Fidelis lead viability is trending lower than Medtronic’s Sprint Quattro defibrillation lead at 30 months (97.7 percent Sprint Fidelis vs. 99.1 percent Sprint Quattro). Medtronic believes that given the performance trend and its ability to identify the primary fracture locations, this action is in patients’ best interest, according to the medical device company.
Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.
A fractured lead "can cause the defibrillator to deliver unnecessary shocks or not operate at all," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
The FDA is expected to make an official statement on Medtronic’s decision later this week.