Medtronic Inc.'s decision to voluntarily recall all Sprint Fidelis defibrillator leads was announced “because of the potential for lead fractures,” but recommended against replacing leads with no apparent problems.
The company identified five deaths “in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor,” Medtronic said in a statement announcing the recall. The clinical signs of lead fractures can include audible alerts, inappropriate shocks, and/or loss of output.
The leads are used with defibrillators, including implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Patients with Medtronic pacemakers are not affected. About 268,000 of these leads (models 6930, 6931, 6948, and 6949) have been implanted worldwide, the company said.
Medtronic has data showing that at 30 months, the viability of the Sprint Fidelis lead is lower than that of the company's Sprint Quattro lead (97.7% vs. 99.1%), which is not statistically different. However, “if the current lead fracture rates become constant,” the difference will become significant over time, the statement said.
The Medtronic statement explains that the company, its independent panel of physicians, and Dr. Bruce Lindsay, professor of medicine and director of cardiac electrophysiology at Washington University, St. Louis, who is also president of the Heart Rhythm Society, “do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture.”
The letter to physicians points out that lead extraction carries risks “that should be considered in patient management,” and that published literature “suggests major complications (death or surgical intervention) from lead extraction range from 1.4% [to] 7.3%. As always, with confirmed lead failure, the risk of extraction should be weighed against the risk of adding an additional lead.”
In a statement issued by the Food and Drug Administration, Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said that based on the agency's initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.
Although this can be frightening to patients, Dr. Schultz added that “patients can be assured that the likelihood of fracture is very low.”
The currently available adverse event data for the leads indicate that fractures have occurred in less than 1% of the approximately 268,000 leads implanted, but whether the rate will increase or remain constant over the life of the leads is unknown, the FDA statement said.
The day after the Medtronic announcement, Sen. Chuck Grassley (R-Iowa) sent a letter to the FDA and Medtronic requesting more information about the recalled leads. And in another letter to the FDA, the public advocacy group, Public Citizen's Health Research Group, requested that the agency conduct an investigation into why the FDA did not compel Medtronic to recall the Sprint Fidelis defibrillator leads earlier this year, when the FDA was aware of “the rapidly mounting number of injury reports” associated with these leads, according to the letter.
The FDA statement says that Medtronic first notified physicians about the lead fracture rate and about the proper method of implantation of the leads in March, and that the decision to suspend marketing of the leads was prompted by “additional data on adverse events” that had accumulated since that time.
Medtronic has posted information for physicians and patients at www.medtronic.com/fidelis