FDA Lauds Market Removal of Defibrillation Leads
Despite small risk of lead fracture, agency cautions against routine surgical removal
WEDNESDAY, Oct. 17 (HealthDay News) -- Patient safety is well-served by Medtronic's voluntary decision to remove its Sprint Fidelis defibrillation leads from the market, according to a statement issued Oct. 15 by Daniel Schultz, M.D., director of the U.S. Food and Drug Administration's Center for Devices and Radiological Health.
"These electronic wires are prone to fracture in a small number of patients, which can cause the defibrillator to deliver unnecessary shocks or not operate at all," Schultz said in a statement. "Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured."
In March, Medtronic notified physicians that fractures had occurred. Subsequent data on adverse events prompted the company's Oct. 15 decision to suspend manufacture and distribution of the leads and pull remaining products from sellers' inventories. According to FDA estimates, fewer than 1 percent of the 268,000 leads implanted worldwide have fractured.
"FDA considers Medtronic's action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action," Schultz said in a statement. "We recognize that some patients and health care professionals might inappropriately interpret the word 'recall' to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed."