Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices

Abstract

When the Food and Drug Administration (FDA) approved the Medtronic Sprint Fidelis implantable cardioverter–defibrillator (ICD) lead in 2004 on the basis of bench testing but no human clinical data, there was no public outcry. Physicians rapidly incorporated the new electrode into their practice, welcoming its small diameter and ease of implantation. During the ensuing 3 years, 90% of Medtronic ICDs were implanted with this lead (see diagram ). But in October 2007, after 38 months on the U.S. market and 268,000 implantations worldwide, the Fidelis was voluntarily recalled by Medtronic because of its propensity to fracture. The large number of affected patients, the billions of dollars at stake in the ICD market, and the controversy surrounding the timing of communication with physicians and patients about the lead's performance highlight the shortcomings of the regulatory system for medical devices and underscore the urgent need for legislation that will ensure adequate protection for the patients receiving them.