Distribution of two types of defibrillators, Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds), is being suspended by Medtronic as a result of lead fractures. If a lead fractures, defibrillators may deliver unnecessary shocks or may not function at all.
Issues with the leads was first noted in March and physicians were notified. Data accumulated since has prompted Medtronic to stop producing, selling, and distributing the Spring Fidelis leads. Products currently on shelves should be returned to Medtronic.
The defibrillator leads recall does not, however, necessitate the surgical removal of already implanted devices at this time; an adjustment of the defibrillator’s settings is recommended. While the rate of adverse effects is currently less than 1%, it is unknown if this rate will increase as more time passes and leads have been in place for longer.
Adverse effects may include major complications or even death. Medtronic has identified five cases in which the faulty leads may be responsible or a contributing factor in the death of the patient.
Patients currently implanted with affected devices–approximately 268,000 worldwide–should speak with their physicians. A small number of non-Medtronic defibrillators are also fitted with the Sprint Fidelis leads. Patients with another manufacturer’s device that utilize the faulty leads, or those unsure of their leads’ manufacturer, should contact their doctor.
