“Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety,” according to Daniel Schultz, MC, director of the Center for Devices and Radiological Health at the FDA.
The formal FDA statement came in response to Medtronic’s voluntary decision to stop selling Sprint Fidelis defibrillation leads.
Schultz also said that the electronic wires used in defibrillators “are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.”
In defense of the use of defibrillators in general, he added, “Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.”