6949

Medtronic 6949 Recall Sprint Fidelis Lead

It is estimated that 188,200 Medtronic 6949 leads were implanted in patients in the United States. The Medtronic lead is also referred to as the “Sprint Fidelis 6949″ heart lead. In October 2007 the 6949 lead was recalled following 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 6949 model, were only used to deliver therapy in defibrillators and they were not used with pacemakers. A fractured lead can cause the implanted defibrillator to either deliver inappropriate shocks or not deliver shocks when needed.

Sprint Fidelis 6949 Lead Fractures

There are two main locations on the 6949 Sprint Fidelis lead where fractures are likely to occur:

1. The distal portion of the lead which affects the anode (ring electrode) and;
2. Near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor.

It is also important to note that the recalled Medtronic Sprint Fidelis 6949 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 6949 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.

• Patients should not routinely 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 6949 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 6949

We represent all Medtronic recall clients with implanted 6949 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.