Medtronic Lead Recall Overview On October 15, 2007, Medtronic, Inc. What are Leads? Leads are wires that connect to the defibrillator. At the time of the recall, there were reports of at least five deaths associated with the defibrillator leads. This means that, although there could be tens of thousands of cases, they are handled individually. However, patients should discuss all options with their physicians. After the discovery stage, the cases are transferred back to the original court where they were filed. The first is a computerized device that monitors the heart rhythms and decides whether to shock the heart. What is a Defibrillator? A defibrillator monitors heart rhythms. If you have one of these models, or are unsure, the Food and Drug Administration recommends contacting your doctor immediately. If you have a wallet card, check the model numbers for 6930, 6931, 6948, and 6949. How Do I Know If My Leads are Defective and What Do I do?
There is no way to test for a lead fracture. Following lead fractures, threaded rod 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. Find more information about Medtronic Recall here. 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. A defibrillator consists of two parts. 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. 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. Author's Resource Box Steve Fields is author of this article on Medtronic Recall. announced that it was recalling its Sprint Fidelis defibrillation leads. 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.
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. 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 announced that the recall was due to the potential for lead fractures. Medtronic and the FDA recommends against having the leads removed because of removal risks. This devise is implanted under the skin near the shoulder. Article Source: 1ArticleWorld. Is there a Class Action Lawsuit? Lawsuits against Medtronic for defective leads are handled through what is called multidistrict litigation, or MDL. They are threaded through veins to specific parts of the heart. The second part of a defibrillator is called leads
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