Implantable Cardioverter Defibrillator Lead Wires: The electronic wires, known as Sprint Fidelis leads, that are attached to implanted heart devices such as ICDs (implantable cardioverter defibrillators) appear to be prone to fracture. These faulty electrical lead wire fractures are failing to provide the correct shock (either no shock or too many shocks) to certain patients who have Medtronic heart devices implanted since 2004.
At issue are Medtronic models 6930, 6931, 6948 and 6949 leads.
Warning from Medtronic: Medtronic recently advised doctors, and now patients have been warned by Medtronic of this risk of the leads failing. The defibrillators with Sprint Fidelis leads are implanted devices with a least one lead connecting the patients heart and the device. The affected Sprint Fidelis leads can often be identified by the Patient ID card which would contain any of these numbers: 6930, 6931, 6948, 6949. (The number usually appears at the start of a long set of numbers on the patient ID card.)
What are the Chances of Failure? Medtronic reports a small chance of fractures on the Sprint Fidelis leads. The FDA says the risk is 1%, but that is based on past adverse event reports. The risk could prove to be much higher now that the public is being made aware and doctors know what to look for.
Should your doctor remove the lead? Patients with Sprint Fidelis leads face a risk in handling this problem as well. While there is a problem with the lead, Medtronic advises that it is even more likely that a patient will experience complications from removal than from a problem with a Sprint Fidelis lead. So it seems that patients are stuck in a dilemma, whether to leave the recalled leads in the body or remove them and face the risks attached with removal. Medtronic says that an independent panel of physicians that they have obtained information from recommends against removing Sprint Fidelis leads except in very unusual circumstances.
Contact A Lawyer:
Many patients with Sprint Fidelis leads are now hearing from their doctor’s office regarding this problem. We think it is wise to stay in close contact with your doctor about this recall and all health considerations. We also encourage you to contact our office for any questions you have about your legal right to hold Medtronic accountable for the faulty lead wires.
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