On October 14, 2007 Medtronic issued a recall for the Sprint Fidelis lead wire commonly used in its defibrillators. Medtronic recalled the device because the electronic wires have a tendency to fracture.

This could lead to device failure or could cause a patient to receive repeated, unnecessary shocks. Medtronic says that at least five patients have died so far because of fractured lead wires.

Lead wires such as the Sprint Fidelis wire are used to connect defibrillators implanted near the shoulder to the heart. These wires deliver a shock from the defibrillator intended to restore the heart to its normal rhythm.

Approximately 235,000 people are currently using defibrillators with Sprint Fidelis leads.

When these leads become fractured, they can cause the defibrillator to deliver repeated and painful shocks to the heart, causing severe injury or death.

According to the consumer group Public Citizen, the Food and Drug Administration has received reports of at least 599 cases of injuries or malfunctions among patients using Sprint Fidelis leads since January.

At least 204 of these patients suffered inappropriate shocks from their defibrillators.

According to Public Citizen, Medtronic and the FDA should have acted quicker to issue a recall for the product. In addition to the hundreds of reports of problems with Sprint Fidelis lead wires, a six-month study published in July raised concerns about the overall safety of the product.

As a result of the Sprint Fidelis recall, Medtronic will no longer sell or manufacture the product and is asking that any remaining lead wires should be taken out of inventory and returned to the company.

The number of reported injuries among those with Sprint Fidelis lead wires rose dramatically between 2006 and 2007. Source: FDA

 
At least five patients have filed Medtronic lawsuits since the company announced the Sprint Fidelis recall.
 
More that 1,000 lawsuits were filed against Medtronic after the company recalled a number of defibrillators prone to battery failure in 2005.

If you have been injured due to a defective Sprint Fidelis lead wire in your defibrillator, you may wish to speak with an attorney to learn more about your legal rights.

(Additional resource on the Medtronic recall) 

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