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 showed the battery is approaching the indicator signifying the time for device replacement. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
It was reported that ten days post implant procedure, the cardiac resynchronization therapy defibrillator (crt-d) had premature battery depletion caused by high threshold measurements of left ventricular (lv) lead. It was noted that the lv lead seem to increase or variate significantly in thresholds. It was also noted that anodal stimulation was observed at lv threshold pacing with high voltage. Due to the covid-19 regulations the patient will not be called in for reprogramming until it is safe. The device and lv lead remain in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5