In today’s New England Journal of Medicine, Dr. William H. Maisel, M.D., M.P.H. , the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, Massachusetts, published an editorial, entitled Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices examining whether consumers can ever recieve adequate protection for faulty medical devices. Dr. Maisel focused his artcle on the recent debacle over defective Medtronic lead wires for their pacemaker/defibrillator models, otherwised known as Implantable Cardio-Defibrillators, or ICDs. Medtronic, at the behest of the FDA, recalled Medtronic Sprint Fidelis lead wires in October, 2007. But according to the article, Medtronic had alerted some doctors via a cryptic letter in March of 2007 that they were detecting a greater number of reports of lead failure, or lead fracture than expected. And by May, 2007, Medtronic had applied for a manufacturing change for the lead wires to correct the manufacturing defects which were causing the lead wire fractures. But for nearly 6 months, Medtronic sold defective defibrillator lead wires, Sprint Fidelis Lead wires, to unsuspecting patients. As reported in the article, the defective lead wires could contribute to significant medical propblems for these patients, including: a failure to pace, a failure to defibrillate, unnecessary shocks, and death.
According to Maisel’s article,
“by October 2007, Medtronic had confirmed the occurrence of 665 fractures in returned leads, five patient deaths to which a Fidelis lead fracture may have contributed, and a 2.3% fracture rate within 30 months of implantation (according to an analysis of the remote-monitoring data)”
For More information about the Maisel artcile in the NEJM, please visit www.nejm.org, or for more information about the litigation regarding these recalled Medtronic lead wires, please visit our website at www.awkolaw.com or www.awkolaw.com//medtronic/news/