DEVICE
NAME:
Medtronic
Sprint Fidelis defibrillation leads
RECALLED
SPRINT FIDELIS MODELS:
6930
6931
6948
6949
FDA
RECALL INFO
Medtronic
Heart (Defibrillator Leads) Wires May Pose More Risk for the Young
Wall Street Journal — October 19, 2007
Medtronic
Heart Device Injuries up in 2007
Reuters — October 16, 2007
Heart
Devices Linked to 5 Deaths Pulled
CBS News — October 15, 2007

On October 15, 2007, Medtronic recalled its Sprint Fidelis defibrillator leads from the market after defective leads were linked to five patient deaths. These electronic wires are prone to fracture which can cause the defibrillator to deliver unnecessary shocks or not operate at all. A fractured wire can cause two serious and frightening problems:
Medtronic, the largest manufacturer of implanted heart devices in the United States, is urging all of the approximately 268,000 patients worldwide (172,000 in the U.S.) with Sprint Fidelis leads, to immediately see their doctors to find out if the wire has fractured. The Sprint Fidelis wire has been used with Medtronic defibrillators since 2004.
The FDA advises patients who have had the Sprint Fidelis lead implanted to contact their doctors, especially if they have experienced the following symptoms:
If you or a loved one has received an implanted Medtronic defibrillator
with Sprint Fidelis leads, contact one of our medical
device attorneys to talk about your case. You may be entitled to full payment
by Medtronic for any additional surgery or medical treatment, as well as
other damages including lost wages and pain and suffering.
Please fill
out and submit the contact form on this page for a free case evaluation
or call us toll-free at (888) 285-3333.
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