Multicenter experience with implantable defibrillators subject to recall.

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.