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Medtronic Lead Recall Overview On October 15, 2007, Medtronic, Inc. announced that it was recalling its Sprint Fidelis defibrillation leads. Medtronic announced that the recall was due to “the potential for lead fractures.” 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. What is a Defibrillator? 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.” What are 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) they deliver information of an abnormal heart rhythm to the defibrillator; and (2) send a shock to the heart when an abnormal rhythm is detected. What is the Problem? 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. The following defibrillators have been recalled due to problems with the leads: • Sprint Fidelis 6930 • Sprint Fidelis 6931 • Sprint Fidelis 6948 • Sprint Fidelis 6949 Approximately 268,000 Sprint Fidelis leads were implanted worldwide. How Do I Know If My Leads are Defective and What Do I do? There is no way to test for a lead fracture. If you have a wallet card, check the model numbers for 6930, 6931, 6948, and 6949. If you have one of these models, or are unsure, the Food and Drug Administration recommends contacting your doctor immediately. For these models, Medtronic and the FDA recommend patients have their defibrillator settings adjusted, which may increase the likelihood that a fracture will be detected before a patient is harmed. Medtronic and the FDA recommends against having the leads removed because of removal risks. However, patients should discuss all options with their physicians. Is there a Class Action Lawsuit? Lawsuits against Medtronic for defective leads are handled through what is called multidistrict litigation, or “MDL.” The lawsuits are pursued individually, but are consolidated for the “discovery” phase and transferred to the federal court in Minnesota, which is where Medtronic is located. After the discovery stage, the cases are transferred back to the original court where they were filed. This means that, although there could be tens of thousands of cases, they are handled individually.
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Steve Fields is author of this article on Sprint Fidelis Recall. Find more information about Sprint Fidelis Recall here.
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