179 Recall alerts in implantable cardioverter-defibrillator recipients: implications for patients and physicians

Backgrounds Implantable cardioverter-defibrillator (ICD) malfunctions sometimes need recall. Despite the increasing number of device implantation, ICD recalls and advisories’ impacts have been little studied. The aim of this study was to determine the rate of ICD generator advisory in our center and to examine its clinical and financial implication. Methods We analyzed weekly FDA Enforcement Reports issued between January 2000 and December 2008 to identify all advisories involving ICD generators and leads. We performed a retrospective analysis of all implanted patients affected by an advisory in our Cardiology department. Results During the 8 years of the study period, 13 advisories were issued for generators and 1 for leads, leading to a total number of 278/1051 (26.4%) device with recall alerts, divided into 196 generator failures and 82 lead failures. Premature generator replacement was performed in 11 patients whereas 9 patients underwent lead replacement. There was no major complications attributable to advisory device replacement, and minor complications occurred only in 1 patient (lead extraction failure). Recalls accounted for 593 extra out-patient visits with a mean number of 2.20 ± 2.19 per patient. The total estimated cost of the device advisories in our population was 334 528 i. Conclusions ICD recalls and safety alerts frequently occur in ICD recipients and tend to increase in number and rate. Although potentially serious, they are not associated with substantial complications. Financial implications are important.