Product analysis: analysis was able to confirm that an error code was encountered on the external pulse generator (epg). Analysis also noted that the main printed circuit board (pcb) was contaminated and failed the incoming functional ventricular pace pulse noise test, the hanger assembly was broken, the upper case was contaminated, the keypad was contaminated, the lower case was broken, the main seal was contaminated, the display was contaminated, the display frame and two display grommets were contaminated, two case screws were contaminated, two main pcb screws were contaminated, and multiple errors were found in the logs. All found defective parts were replaced and all other identified issues were resolved. The device passed all final functional tests. 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 an error code was encountered on the external pulse generator (epg). The epg was returned for service. There was no patient involvement. It was further reported that the epg subsequently tested out of specification during manufacturer's analysis.
Patient Sequence No: 1, Text Type: D, B5