Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a full electrical reset.If information is provided in the future, a supplemental report will be issued.
|
It was reported that the implantable cardiac monitor (icm) was explanted and then re-implanted due to patient discomfort.It was also reported that, after repositioning, the icm experienced a power on reset (por).The icm was reprogrammed and remains in use.No further patient complications have been reported as a result of this event.
|