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Medtronic Defibrillator Wire Problems

The Sprint Fidelis lead wire is designed to connect a patients Medtronic defibrillator directly to the heart. In the event that a patient’s heart begins beating too fast—such as during a heart attack—the defibrillator is designed to deliver an electrical charge through the Sprint Fidelis leads.

When it operates correctly, this charge can restore the patient’s heart back to its normal rhythm.
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Medtronic recalled the Sprint Fidelis leads on October 14 due to an increased risk of injury for some patients. According to the company, these lead wires are at an increased risk of fractures.

When fractures in the lead wires occur, they could cause the defibrillator to fail to deliver a life-saving jolt in the event of a heart attack, or could cause the device to deliver painful, unnecessary shocks to the heart.

Medtronic has stated that about one in 43 patients with a defibrillator containing one of the Sprint Fidelis leads will experience one of these fractures.

This is more than twice the rate of other lead wires manufactured by Medtronic.

The Food and Drug Administration has received at least 599 reports of injury due to Medtronic defibrillator wire problems as of January 2007.

At least 204 of these patients received unnecessary, painful shocks to the heart because of fractures that occurred in their Sprint Fidelis leads.

Patients with a defibrillator involved in the Medtronic lead recall have been advised to talk with their doctors about treatment options to prevent injury from the Sprint Fidelis leads.

The FDA says that patients may with to have the lead wires adjusted, replaced or removed.

Several patients who allege they were injured due to problems with the Sprint Fidelis leads have filed Medtronic defibrillator lawsuits against the company.

These patients have alleged that Medtronic knew about problems with the lead wires long before it issued the defibrillator recall.

 

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