Product-experience reporting on endocardial defibrillation leads: A 4-year national perspective

Luigi Padeletti, Carlo Pappone, Antonio Curnis, Gabriele Zanotto, Leonardo Caló, Giuseppe Ricciardi, Paolo Pieragnoli, Cristina Dondina, Giovanni Raciti, Antonio Michelucci

Research output: Contribution to journalArticlepeer-review

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 languageEnglish
Pages (from-to)383-388
Number of pages6
JournalExpert Review of Medical Devices
Volume6
Issue number4
DOIs
Publication statusPublished - 2009

Keywords

  • Endocardial lead
  • Implantable cardioverter-defibrillator
  • Patient safety
  • Product performance report

ASJC Scopus subject areas

  • Surgery
  • Biomedical Engineering

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