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Medtronic heart device problems were reported in February 2005, when a potential battery short resulted in a recall of several models of the company’s implantable defibrillators, the heart device designed to normalize irregular heart rhythms.

The most recent Medtronic heart device problem concerns the lead wire components of defibrillators. In an October 2007 news release, Medtronic explained that their Sprint Fidelis leads can fracture, resulting in inadequate or inappropriate shocks being administered to patients.

Deaths Linked to Defective Leads

Medtronic has acknowledged that five patient deaths may be due to Sprint Fidelis lead malfunction. A fracture or break in the lead can cause the defibrillator to deliver an unnecessary electrical shock or fail to provide a life-saving electric shock at a time when the patient needs one.

About 268,000 patients worldwide have received Sprint Fidelis leads since their introduction to the market in 2004. Other patients with defibrillators who have had their devices replaced since 2004 may have a Sprint Fidelis lead, although the number of such patients is small.

Recall Announced

As of October 2007, Medtronic voluntarily ceased the sale and distribution of Sprint Fidelis leads, and said it was in the process of contacting the 13,000-plus physicians worldwide who are treating patients with the leads. The company said it was also trying to contact the patients directly, advising them to see their physicians for further information.

Patients who have Sprint Fidelis leads should contact their physicians. The leads are threaded through a blood vessel to connect a defibrillator to the heart, and removal of the lead is more dangerous than the risk of lead malfunction, according to Medtronic and the FDA. Reprogramming of the lead is a suggested option.

Medtronic has provided a toll-free number for patients who are concerned about their defibrillator leads: 800-551-5544, ext 41835.

Consult a Defective Device Attorney

If you or a loved one received a defibrillator with a Sprint Fidelis lead, talk to your physician today, and contact our Medtronic lawyers who represents victims of defective heart devices. You may be eligible for monetary compensation.

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