Medtronic Recall – Sprint Fidelis defibrillator leads
October 15, 2007 Medtronic, the leader of implantable heart devices, issued a voluntary recall of their Sprint Fidelis defibrillation leads. The leads can break causing the defibrillator to malfunction causing unnecessary shocks to the heart or to not function at all when needed. 268,000 Sprint Fidelis leads have been implanted worldwide including 172,000 in the United States. Medtronic has instructed physicians worldwide to discontinue use of these leads and instructed them to return any leads they have in their inventory.
A lead is part of an implantable heart defibrillation system. The lead is a thin insulated wire that runs from the defibrillator into the heart to detect the hearts rhythm. The lead sense the heart’s rhythm and the defibrillator delivers therapy (correction of a fast or slow heart rate) as needed.
Affected defibrillator models are 6930, 6931, 6948 and 6949.
Our firm is investigating claims arising from defibrillators which have malfunctioned. If your physician has recommended that you have removal or replacement of the lead to your defibrillator you should check your identification card to determine if it is a Medtronic Sprint Fidelis Lead.
You should contact your physician, especially if you have experienced multiple shocks, lightheadedness, fainting or palpations. If you are not experiencing any problems, the FDA has stated that patients should not routinely request removal of the device as the risks of removal far exceeds the small risk of lead fractures.
If you have an effected defibrillator model, contact Ward Black Law today at 1-800-531-9191 for a free consultation or contact us via email.