How many patients has Cleveland Clinic implanted with these specific defibrillator leads?
We have about 1500 patients with these leads. What is the problem with the leads? These leads or 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. Medtronic’s initial review of reported adverse events found that some deaths and major complications have occurred after the leads have fractured. How do I know if my lead is defective? There is no test to predict which lead will fracture. The Food and Drug Administration (FDA) and Medtronic recommend that defibrillator settings be adjusted at each patient’s next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed. Also, Cleveland Clinic patients need to make sure that they are enrolled in our remote monitoring program to ensure the integrity of their device is monitored continuously by Cleveland Clinic staff. What now? The Sprint Fidelis leads will
