The Medtronic Sprint Fidelis 6948 lead was removed from the market by Medtronic on October 15, 2007 due to the reporting of fractures in some wires and five patient deaths associated with the defibrillator leads. It is estimated there are around 268,000 Medtronic leads implanted in patients around the world. Medtronic’s Sprint Fidelis defibrillation leads were recalled because the leads (electronic wires) are prone to fracture or break causing major complications and the potential for patient fatalities. Lead fractures, or breaks, can cause the defibrillator to deliver an unnecessary shock to the heart, or fail to deliver a shock when one is needed. Following lead fractures, some patients have died and many others have reported experiencing problems including unnecessary shocks and jolts. These Medtronic defibrillators have been recalled due to problems with the leads: • Sprint Fidelis 6930 • Sprint Fidelis 6931 • Sprint Fidelis 6948 • Sprint Fidelis 6949 At the time of the recall, there were reports of at least five deaths associated with the defibrillator leads. The Food and Drug Administration classified the recall as “Class 1,” which is the most serious type of recall and involve situations where there is a reasonable probability that the use of the product will cause serious injury or death. Patients with the implanted Spring Fidelis have reported experiencing complications as a result of defective leads such as unnecessary shocks or jolts or not operating at all. In their October 15, 2007 letter to patients, Medtronic states that patients with a Sprint Fidelis lead “…are more likely to experience complications from removal than from a problem with a Sprint Fidelis lead”. Patients who have the implanted defective Medtronic leads subject to the recall are forced into the difficult position of deciding whether to have the leads removed or risk future potential problems. There is currently no test that will predict if a Medtronic lead will fracture. The FDA advises that defibrillator settings be adjusted so that potential fractures can more easily be detected in patients. A defibrillator monitors heart rhythms. If it detects an unstable rhythm, it delivers an electric shock to the heart (approximately 750 volts, which is more than 100 times the shock delivered by a pacemaker) to shock the heart back to normal. A defibrillator consists of two parts. The first is a computerized device that monitors the heart rhythms and decides whether to shock the heart. This devise is implanted under the skin near the shoulder. The second part of a defibrillator is called “leads.” Leads are wires that connect to the defibrillator. They are threaded through veins to specific parts of the heart. The leads perform two functions: 1) deliver information of an abnormal heart rhythm to the defibrillator 2) send a shock to the heart when an abnormal rhythm is detected Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat patients with abnormal heart rhythms that can cause the heart to suddenly stop. Implanted defibrillators shock the heart back into normal rhythm by transmitting pulse of energy through an electronic lead (wire) that is connected to the patient’s heart. Patients should check their wallet card for the model number 6948. If they have this Medtronic lead one of the other models, or are unsure, the FDA recommends for patients to contact their doctor immediately. There is no way to test for defective leads, but Medtronic and the FDA recommend patients have their defibrillator settings adjusted, stating that this adjustment may increase the likelihood that a fracture will be detected before a patient is harmed. Medtronic and the FDA advise against automatically having the leads removed because of removal risks. Patients should discuss with their doctor both of these options.
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The Medtronic Sprint Fidelis 6948 lead was removed from the market by Medtronic on October 15, 2007 due to the reporting of fractures in some wires and five patient deaths associated with the defibrillator leads. It is estimated there are around 268,000 Medtronic leads implanted in patients around the world. Medtronic’s Sprint Fidelis defibrillation leads were recalled because the leads (electronic wires) are prone to fracture or break causing major complications and the potential for patient ...
David Johnson is author of this article on Medtronics recall. Find more information about Medtronics lawsuit here.
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