6931

Medtronic 6931 Recall Sprint Fidelis Lead

It is estimated that 8,300 Medtronic 6931 leads were implanted in patients in the United States. This Medtronic lead which was part of the 2007 recall is also referred to as the “Sprint Fidelis 6931″ heart lead. In October 2007 the 6931 lead was recalled following increasing reports of lead fractures. The leads (wires) connect a defibrillator to the heart by placing the leads in or on the heart muscle. The recalled Medtronic leads, including the Medtronic 6931 model, were only used to deliver therapy in defibrillators and they were not used with pacemakers. A fractured lead can send false signals that cause defibrillator shocks or not deliver pacing or shocks when needed.

Sprint Fidelis 6931 Lead Fractures

Even though the recalled Medtronic leads are more likely to fracture, it doesn’t mean that every lead will break. However, when a lead does break, the lead can send false signals that cause unnecessary shocks or in the alternative packing or shock therapy many not be delivered when needed. Even though monitoring software is used, there is currently no reliable test to detect whether any of the recalled Medtronic leads will fracture.

It is also important to point out that the recalled Medtronic Sprint Fidelis 6931 leads were not only implanted in patients with Medtronic defibrillators. The leads were also used with defibrillators from other manufacturers such as St. Jude and Boston Scientific/Guidant. It is important to check your patient wallet card to identify which lead was implanted.

FDA Patient Recommendations

What should patients do if they have had a Medtronic Sprint Fidelis 6931 lead implanted?

• Patients who have had the Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.

• Neither Medtronic nor the FDA recommends that patients have recalled leads surgically removed unless the risk of leaving the lead implanted is greater than monitoring the lead or having it capped. seek removal of the device. The risks of removal in most patients exceed the small risk of lead fractures. Therefore, it is generally recommended to leave functioning leads in place. There are two alternatives to removing the lead. One is to continue using the lead while monitoring closely for signs of fracture. A second is to surgically add a replacement lead. Adding a replacement lead does not require removing the 6931 Medtronic lead. If the Sprint Fidelis is left in a patient without being used, it must be “capped”, which means covering the tip with a small plastic insulation.

Medtronic Recall Lawsuit 6931

We represent all Medtronic recall clients with implanted 6931 leads on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call Toll Free at 1-888-343-5375 or fill out our short online contact form and an attorney will contact you to answer any of your questions.