There was no patient involvement.Livanova (b)(4) manufactures the s5 control panel mrp 85.The incident occurred in (b)(6).The affected device was requested back to the manufacturer site for further investigation.The serial read-out analysis identified events of a can-bus interruption, thus confirming the claimed issue.The investigation of the returned device could not reproduce the failure despite intensive testing.The root cause of the reported failure could not be identified.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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