Section h6 investigation findings: 3221 - no findings available - additional information about the event was requested from the study site on (b)(6) 2022.(b)(6) 2022-09-30, 2022-10-17; however no further information was provided investigation conclusions: 67 - no problem detected - review of the manufacturing records did not identify any problems with the device.4315 - cause not established - the root cause of the event could not be determined, due to lack of information provided.Patient recovered.Adverse event resolved without sequelae.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
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