Medtronic Sprint Fidelis Recall
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by: Steve Fields294
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Medtronic, Inc. announced that it was recalling its Sprint Fidelis defibrillation leads on October 15, 2007. Medtronic represented that the recall was due to “the potential for lead fractures.” At the time of the recall, reports had been made of at least five deaths associated with the defibrillator leads. The Food and Drug Administration, or FDA, classified the recall as “Class 1.” A Class 1 recall is the most serious type of recall because it implicates situations where there is a reasonable probability that the use of the product will cause serious injury or death.
Is there a Class Action Lawsuit Against Medtronic?
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.
How Does a Defibrillator Function?
A defibrillator monitors rhythms in a person’s heart. If the defibrillator detects an unstable heart rhythm, it delivers an electric shock to the heart so that the heart rhythm returns to normal. The electric shock is strong; it is approximately 750 volts, which is more than 100 times the shock delivered by a pacemaker. A defibrillator contains two parts: (1) a computerized device implanted under the patient’s skin by the shoulder that monitors the heart rhythms and decides whether to shock the heart; and (2) “leads.”
How Do the Leads Work?
Leads are wires that connect to the heart and defibrillator together. The leads are inserted from the defibrillator through veins to specific parts of the heart. The leads perform two functions. First, they signal an abnormal heart rhythm to the defibrillator. Second, if this signal is received, they send a shock from the defibrillator to the heart.
Problems with the Leads.
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
Approximately 268,000 Sprint Fidelis leads were implanted worldwide.
How to Detect if Leads Are Defective and What to Do About It.
Patients should check their wallet card for the model numbers 6930, 6931, 6948, and 6949. If they have one of these 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 having the leads removed because of removal risks. Patients should discuss with their doctor both of these options.
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About the Author
Steve Fields is author of this article on Medtronic Defibrillator Lawyer. Find more information about Medtronic Defibrillator Lawyer here.
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