In October 2007, Medtronic Inc., one of the largest medical device manufacturers in the world, initiated a recall of its Sprint Fidelis leads, which are used in implantable defibrillators and pacemakers.

A defibrillator monitors a patient's heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.

The leads are electrical wires, and Medtronic announced that several of the leads it sells were defective and may have contributed to the deaths of at least five patients by failing to deliver a necessary shock. The company said the lead wires are prone to fracture and failure within 14 month after implant.

The Fidelis wire, or lead, is used on about 60 percent of Medtronic defibrillator implants. There are an estimated 270,000 wires currently implanted. The Sprint Fidelis models affected are:

• Sprint Fidelis® 6930
• Sprint Fidelis® 6931
• Sprint Fidelis® 6948
• Sprint Fidelis® 6949

The company is asking doctors to stop implanting the leads and return unused leads to Medtronic. Medtronic and the FDA estimated that fractures have occurred in less than 1 percent of those leads.

The Sprint Fidelis was introduced in 2004 with thinner leads and was intended to replace the Sprint Quattro leads in use since 2001. But Medtronic said it noticed that after 2 ˝ years in patients, 99.1 percent of the Quattros were still viable, but only 97.7 percent of the Fidelis leads were still viable. Medtronic said the difference between the two was not statistically significant yet but would have become significant as more Fidelis leads were implanted.

The Food and Drug Administration (FDA) approved the first cardiac implantable defibrillator (ICD) over 10 years ago. ICDs are designed to shock a heart with an abnormal beat back to a normal rhythm, but defects have caused some devices to malfunction, leading to injuries and even deaths.

Sales of implantable defibrillators were once a source of rapid growth for Medtronic, but recalls beginning in 2005 stalled that growth. First Medtronic recalled some of its implantable defibrillators that year because their batteries were draining without warning. Then a competitor, Guidant, began the first of a series of major recalls.

That prompted some heart patients to avoid getting a defibrillator, and some doctors to treat their symptoms with drugs instead of a device implant. Medtronic responded by stepping up its efforts to convince doctors that even with the risks of malfunction, implantable devices were still safer than no device at all.

If you or a loved one were implanted with a Medtronic Sprint Fidelis lead wire (Model 6930, 6931, 6948, or 6949), you may have a valuable claim against Medtronic. Consult one of our product liability lawyers immediately to discuss your case and make an important step in taking control of your situation. At Epperly & Follis, P.C, we do not approach our cases as mere jobs, but as causes in which larger issues are at stake - causes in which our firm's lawyers invest personal dedication to see that justice is done.

Our skilled team of lawyers know the law, the legal process and victim's rights. We can help you make informed decisions, so please call Epperly & Follis, P.C today at 1-888-703-0109 or (804) 648-6480, or contact us via our online Contact Form.