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Volume 358:985-987 March 6, 2008 Number 10 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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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 . . . [Full Text of this Article]

Source Information

Dr. Maisel is the director of the Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston.

Related Letters:

Medical-Device Safety and the FDA
Schultz D. G., Maisel W. H.
Extract | Full Text | PDF  
N Engl J Med 2008; 359:88-89, Jul 3, 2008. Correspondence

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