Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices

• Published in: The New England journal of medicine Vol. 358; no. 10; pp. 985 - 987
• Main Author: Maisel, William H
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 06.03.2008
• Subjects: Consumer Product Safety - legislation & jurisprudence; Defibrillators, Implantable - standards; Device Approval - legislation & jurisprudence; FDA approval; Humans; Manufacturing; Medical equipment; Patient Rights; Product Surveillance, Postmarketing; Prostheses and Implants - standards; Prosthesis Failure; United States; United States Food and Drug Administration; United States
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMp0800495

In October, after 38 months on the U.S. market and 268,000 implantations worldwide, the Medtronic Sprint Fidelis was voluntarily recalled because of its propensity to fracture. Dr. William Maisel writes that the controversy highlights the shortcomings of the regulatory system for medical devices and underscores the urgent need for legislation that will ensure adequate protection for patients. 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 . . .