Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress

Because it is a lifesaving device, the unexpected failure of an ICD can be catastrophic. We report ICD electronic circuit failure due to electrical ov erstress damage (EOS) to the high voltage hybrid circuit and other electron ic components in a series of ICD pulse generator models. Data were obtained from the Multicenter Registry of Pacemaker and ICD Pacemaker and Lead Fail ures, and from the manufacturers' adverse event reports, that were in the F DA's Manufacturer and User Facility Device Experience (MAUDE) database. Of 16 nonbattery Guidant/CPI ICD pulse generator failures reported to the regi stry 6 (38%) have been confirmed by the manufacturer to be EOS related, and Guidant/CPI has reported 273 such failures to the FDA as of 12/29/00. The signs of failure included loss of telemetry and inability to deliver therap y, and some patients have experienced serious adverse events. Hybrid circui t damage may have occurred during capacitor charging or reform, and the maj ority appears to have happened during normal ICD function. While the incide nce of this problem is unknown, a management strategy should be adopted tha t includes routine follow-up every 3 months and device evaluation after a s hock or exposure to external defibrillation or electrosurgical devices. Thi s study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performan ce of ICDs following market release are inadequate.