On October 15, 2007, Medtronic informed patients with Sprint Fidelis lead Model 6949 that their defibrillation lead was recalled. The Medtronic recall also affected patients with lead Models 6930, 6931 and 6948. Patients can identify which Medtronic lead they have by referring to their Patient ID card (wallet card) which will contain the model of their implanted lead. If a patient is unsure about which lead they have implanted they should consult with their physician. A total of 268,000 Sprint Fidelis leads were implanted worldwide, with 172,000 leads implanted in the United States. As of January 2007, approximately 144,311 Medtronic Sprint Fidelis Model 6949 leads had been implanted. Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms in patients which can cause the heart to suddenly stop. ICDs and CRT-Ds shock the heart back into normal rhythm by delivering a pulse of energy through an electronic wire (lead) that is connected to the heart. ICDs consist of a generator, a processor and a lead. The lead works to conduct the electrical impulses between the heart and the ICD. Low voltage pacing therapy to treat slow heart rhythms is provided through pace-sense electrodes. High voltage defibrillation shocks are delivered through high voltage conductors. Medtronic’s Sprint Fidelis leads were introduced in 2004 as a replacement for the Sprint Quattro Secure Lead Model 6947 (referred to as “Quattro leads”). The Sprint Fidelis leads were marketed as being smaller and more effective for patients with implantable cardiac defibrillators (ICDs). By October 2007, Medtronic had notice of at least 665 chronic fractures in returned Sprint Fidelis leads. The majority of these fractures are in the Model 6949 Medtronic lead. It has been argued that Medtronic was aware that their Sprint Fidelis leads survival rate was unacceptable when compared to industry failure rates. Where a lead breaks, or “fractures”, the lead may send false signals which can cause the defibrillator to deliver inappropriate shocks or in the alternative shocks may not be delivered when needed. There is currently no test to predict which leads will fracture and the FDA is encouraging patients to seek follow-up care with their doctor to discuss options. It is not recommended that patients automatically have a fractured lead removed due to the risks involved with a surgical removal. There are two main locations on the recalled Medtronic leads where fractures have occurred: 1. The distal portion of the lead which affects the anode (ring electrode) and; 2. Near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor. Physicians are urged to analyze the risks versus benefits of either leaving the lead implanted along with careful monitoring or implanting a different lead model. Extraction of leads involves serious risks to the patient. Some of the reported complications of lead removal include: lead breakage and migration; avulsion of veins, myocardium of the tricuspid valve; tears of the myocardium or veins; hemothorax, tamponade, perforation, emergency cardiothoracic surgery, pulmonary emboli, and death. As recently as May 2008, Medtronic has continued to maintain that routine monitoring is the preferred option for patients rather than lead removal due to the risks involved with extraction of the lead.
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On October 15, 2007, Medtronic informed patients with Sprint Fidelis lead Model 6949 that their defibrillation lead was recalled. The Medtronic recall also affected patients with lead Models 6930, 6931 and 6948. Patients can identify which Medtronic lead they have by referring to their Patient ID card (wallet card) which will contain the model of their implanted lead. If a patient is unsure about which lead they have implanted they should consult with their physician.
David Johnson is author of this article on Medtronics recall. Find more information about Medtronics lawsuit here.
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