Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices  

Oleh:

Maisel, William H.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 358 no. 10 (Mar. 2008), page 985.

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K.2008.02 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

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 . . .

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