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.

Keywords::

• endocardial lead
• implantable cardioverter–defibrillator
• patient safety
• product performance report

Financial & competing interests disclosure

Giovanni Raciti and Cristina Dondina are employed at Boston Scientific, Italy. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.