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.
Original language | English |
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Pages (from-to) | 383-388 |
Number of pages | 6 |
Journal | Expert Review of Medical Devices |
Volume | 6 |
Issue number | 4 |
DOIs | |
Publication status | Published - 2009 |
Keywords
- Endocardial lead
- Implantable cardioverter-defibrillator
- Patient safety
- Product performance report
ASJC Scopus subject areas
- Surgery
- Biomedical Engineering