Product analysis: analysis was able to confirm the customer comments that the external pulse generator (epg) had an issue with the ventricular output connector, was emitting a rattling noise and had knobs missing.It was noted that the ventricular output connector was broken, two upper case bosses were broken resulting in debris making rattling noise, and two encoder knobs were missing.It was further noted that the hanger assembly was cracked, lower case was broken, main label and manufacturing label were damaged and insulator label was contaminated.All found defective parts were replaced and all other identified issues were resolved with firmware up dated and the epg passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
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