Defibrillator leads that connect an implanted defibrillator have been recalled. The defective medical device is made by Medtronic and may cause the device to function incorrectly. The name of the product is Medtronic Sprint Fidelis Defibrillator Leads.
The FDA has advised patients who are implanted with this recalled Medtronic defibrillator lead or do not know the model of their lead, to contact their physicians for further information. Patients who have had the Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.
The recalled device may stop working or it may deliver a shock when none is needed. There are fractures in the leads causing problems in the defibrillator.