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Medtronic Lead Recall

On October 14, Medtronic Inc. issued a recall of the Sprint Fidelis lead wire, used in many defibrillators manufactured by the company.

The Medtronic lead recall was issued after the company found that they were more likely to fracture after a defibrillator is implanted than other wires.

At least five deaths so far have been linked to problems with the Sprint Fidelis leads.

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According to Medtronic, a fracture in one of the Sprint Fidelis leads can cause the defibrillator to fail to deliver a lifesaving jolt of electricity in the event of a heart attack, or could cause the device to deliver painful, unnecessary shocks to a patients heart.

The consumer group Public Citizen says that Medtronic may have waited too long to issue the lead wire recall.

According to Food and Drug Administration statistics compiled by the group, there have been at least 599 injury reports for patients wearing a device with one of the Sprint Fidelis leads, including at least 204 patients who were inappropriately shocked.

Experts say that about one in 43 Sprint Fidelis leads will fracture within 30 months of implantation. This is more than twice the rate of other Medtronic leads.

With about 250,000 patients currently wearing defibrillators with one of the recalled leads, this could mean that thousands of patients are at risk of injury from defibrillator wire problems.

ImageMore than 1,000 Medtronic defibrillator lawsuits have already been filed against the company over a 2005 defibrillator recall concerning battery problems in the devices.

Financial experts say that even more Medtronic lawsuits could be filed over problems with the Sprint Fidelis leads.

 

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