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Medtronic receives approval for new defibrillator lead wire |
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Thursday, 04 December 2008 |
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Medtronic Inc. has announced that it has received Food and Drug Administration approval for a new type of lead wire for use with the company’s defibrillators. The company says that its new Sprint Quattro Secure S single coil defibrillator lead can be used with any of the company's current defibrillators.
The stopwatch-sized defibrillators manufactured by Medtronic or other companies are designed to send electrical shocks to the hearts of patients who have an irregular heartbeat. Lead wires such as the Sprint Quattro Secure model are designed to connect the defibrillator to the heart and deliver the electrical charge sent by the device.
In October 2007, Medtronic issued a recall on its Sprint Fidelis lead wires after several patients died due to fractures in their defibrillator leads. Fractures in the Sprint Fidelis leads could cause a patient’s defibrillator to deliver repeated, painful and unnecessary shocks to the heart, which could be fatal. The FDA reported more than 1,600 cases of injury or malfunction among patients using the lead wires at the time of the Sprint Fidelis recall. |