Multicenter experience with implantable defibrillators subject to recall

Laura Perrotta, Paolo Pieragnoli, Giuseppe Ricciardi, Stefania Sacchi, Giuseppe Mascia, Margherita Padeletti, Maria Grazia Bongiorni, Antonio Curnis, Fulvio Bellocci, Antonio Michelucci, Maria Cristina Porciani, Luigi Padeletti

Research output: Contribution to journalArticle

Abstract

Background: The management of implantable cardioverter defibrillators (ICDs) affected by advisories, which often include generator replacement, is complex and the risk of device failure needs to be carefully assessed for each patient. Methods: We analyzed the response to the advisory communication in the Italian centers involved in the recall for the Prizm 1861 and Renewal (Boston Scientific-formerly Guidant-St. Paul, MN, USA) communication. Results: One hundred and thirty-nine of 843 Prizm (16.5%) and 458 of 2,342 Renewal devices (19.6%) were explanted. The total incidence over a 4-year time frame of the failure event was equal to zero of 710 (0%) for Prizm ICDs and eight of 2,342 (0.34%) for Renewal ICDs. A limited percentage of devices affected by recall were definitely explanted following the indications stated by the advisory. The failure rates that resulted from analysis of our data (0% for Prizm and 0.34% for Renewal) were inferior to those already found or projected along the device lifetime globally, as reported in the most recent Company Product Performance Report (0.72% for Prizm and 1.83% for Renewal). Conclusions: In absence of underestimation of the events, a lower incidence than expected could resize the dimension of the problem, justifying the concept of a more frequent follow-up of patient with respect to the choice of an immediate device explant.

Original languageEnglish
Pages (from-to)998-1002
Number of pages5
JournalPACE - Pacing and Clinical Electrophysiology
Volume34
Issue number8
DOIs
Publication statusPublished - Aug 2011

Keywords

  • advisories
  • device failure
  • implantable cardioverter defibrillator
  • risk analysis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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  • Cite this

    Perrotta, L., Pieragnoli, P., Ricciardi, G., Sacchi, S., Mascia, G., Padeletti, M., Bongiorni, M. G., Curnis, A., Bellocci, F., Michelucci, A., Porciani, M. C., & Padeletti, L. (2011). Multicenter experience with implantable defibrillators subject to recall. PACE - Pacing and Clinical Electrophysiology, 34(8), 998-1002. https://doi.org/10.1111/j.1540-8159.2011.03083.x