(b)(4).The device was returned for evaluation.Visual inspection, functional testing, electrical testing, and a simulated therapy session were performed with no issues related to the reported problem identified.A device history record review and a service history record review were performed and revealed no issues that could have caused or contributed to the reported issue.An event history log review was performed and showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The reported condition was unable to be verified.Should additional relevant information become available, a follow up report will be submitted.
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