The customer did not return the device for evaluation.A review of the device history record for sn (b)(4) was performed from 12/10/2018 to 3/4/2020 and confirmed that this device was previously returned for servicing and there were no production failures which correlates to the customer reported issue.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for 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.The customer stated that there was no patient involvement.
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