This reported event and any subsequent repairs have been investigated through the normal service repair process.Failure data and parts used information, was reviewed for the sap file and track wise file, and found to be relevant to the service repair.A review of the source device service history record was performed beginning from the date of manufacture to the present date.Service returns were for unrelated issues.The database showed no quality notifications were opened for the source device.A review of the device history record in sap for sn (b)(4) was performed which confirmed that this device was not involved in a production failure and product was returned for the servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.Capa reference: (b)(4).The customer stated that there was no patient involvement.
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