Additional information is provided in h.3, h.6 and h.10.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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