The reported event of pacing problem was not confirmed, and the reported event of setscrew issue was confirmed.The device was above elective replacement indicator (eri) level upon receipt.Both setscrews were able to tighten upon receipt.Analysis found that a setscrew insets was stripped due to material inside the inset preventing full wrench insertion of wrench, this is consistent with user error, which resulted in the reported event of the setscrew.Further analysis performed, including output verification and inspection of header and connectors showed normal device characteristics with no anomalies contributing to reported event of pacing problem.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.A device history record (dhr) review was performed, and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
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