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Updated: Jun 22, 2026

A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Product-experience reporting on endocardial defibrillation leads: a 4-year national perspective
Luigi Padeletti1, Carlo Pappone, Antonio Curnis
1Institute of Internal Medicine and Cardiology, Careggi Hospital, University of Florence, Viale Morgagni 85, 50134 Firenze, Italy. lpadeletti@interfree.it
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.
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