title: Product-experience reporting on endocardial defibrillation leads: a 4-year national perspective.
abstract: The medical device industry must implement accurate programs to monitor product performance once the product is released into the market. Product-experience reports provide a means for physicians who use medical devices to provide continuous feedback to manufacturers in order to monitor device performance. We examined product-experience reports sent from Italy over 4 years (2004-2007) related to a single manufacturer's family of permanent endocardial leads (Endotak Reliance, Boston Scientific, MA, USA) used with implantable cardioverter-defibrillators. Out of 15,772 implanted leads, physicians sent in 454 (2.87%) product-experience reports. Only 126 out of 454 (28%) leads were returned to the company; most of these (101 out of 126; 80%) were related to implant procedure. Laboratory analyses of returned leads rarely showed loss of integrity (0.01%). The practice of reporting product performance and returning the device to companies should be strongly encouraged in order to better identify potential issues affecting implantable devices.
authors: Institute of Internal Medicine and Cardiology, Careggi Hospital, University of Florence, Viale Morgagni 85, 50134 Firenze, Italy. lpadeletti@interfree.it
authors: Luigi
authors: L
authors: Padeletti
authors: Carlo
authors: C
authors: Pappone
authors: Antonio
authors: A
authors: Curnis
authors: Gabriele
authors: G
authors: Zanotto
authors: Leonardo
authors: L
authors: Calò
authors: Giuseppe
authors: G
authors: Ricciardi
authors: Paolo
authors: P
authors: Pieragnoli
authors: Cristina
authors: C
authors: Dondina
authors: Giovanni
authors: G
authors: Raciti
authors: Antonio
authors: A
authors: Michelucci
mesh_terms: D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000706:statistics & numerical data*; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis / Q000706:statistics & numerical data*; D007558:Italy; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D012189:Retrospective Studies