ROCKVILLE, Md. -- Fractures of Sprint Fidelis defibrillator leads have triggered a voluntary move by Medtronic to stop selling them, a decision that was promptly endorsed by the FDA.
ROCKVILLE, Md., Oct. 15 -- Fractures of Sprint Fidelis defibrillator leads have triggered a voluntary move by Medtronic to stop selling them, a decision that was promptly endorsed by the FDA.
Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, said the recall, as defined by the FDA, was "in the best interest of patient safety." He said that use of the term recall does mean that the leads should be surgically removed, but rather that the devices should not be sold.
Medtronic first reported problems with the Sprint Fidelis leads to the FDA last March. Dr. Schultz said the FDA's preliminary review of reported adverse events suggested that "some death and major complications have occurred after the leads have fractured.
But he said the absolute rate of lead fracture is small -- less than 1% of the approximately 268,000 of these leads implanted worldwide.
Dr. Schultz said, however, that it was unknown "if this rate of adverse events will remain constant or increase over the life of these leads."
A fractured lead may cause an implantable cardioverter defibrillator to deliver unnecessary shocks or to fail to deliver needed shocks.
The FDA agreed with the suggestion from Medtronic that defibrillator settings be adjusted at the patient's next scheduled follow-up visit with their doctor. Medtronic said the adjustment might increase the likelihood that a fracture will be detected before a patient is harmed.
Another option for physicians monitoring patients would be capping the lead so it is no longer useable and implanting a different model.
Medtronic said no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. The company advised patients who have been implanted with ICDs using Sprint Fidelis leads to consult their physicians.