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Medtronic Sprint Fidelis Heart Lead Wire
On October 15, 2007, Medtronic issued a statement in which it suspended the sale and shipment of its heart lead wire products and requested that all unused heart lead wire products be returned immediately to Medtronic.
The reason for the recall of the Sprint Fidelis heart lead wire products was due to reports of several patient deaths associated with the heart lead wires because the heart lead wires were prone to cracking and potentially life-threatening consequences such as firing repeatedly, unnecessary shocks and/or not sending an electrical jolt when needed.
Some of the warning signs may include:
- excessive shocks
- lightheadedness
- fainting
- palpitations
In addition, the Food and Drug Administration (“FDA”) issued a Class 1 recall (the most stringent) of the Medtronic Sprint Fidelis heart lead wires. The recalled Medtronic Sprint Fidelis heart lead wires have been implanted in an estimated 268,000 patients worldwide since late 2004.
The Medtronic Sprint Fidelis heart lead wire is connected to defibrillators or pacemakers either made by Medtronic or by another heart device manufacturer such as Guidant or St. Jude. The Medtronic Sprint Fidelis heart lead wires that are subject to the FDA recall are the following model numbers:
In order to determine if you have one of Medtronic’s Sprint Fidelis heart lead wire products, just review your patient i.d. card and look for the manufacturer name -“Medtronic”- and one of the following numbers – “6949”, “6948”, “6931” and “6930”.
If you experience any problems - lightheadness, palpitations, multiple shocks or fainting - with your heart device, please contact a doctor immediately.
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