The customer¿s reported problem cannot be confirmed.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 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 is no patient involvement.
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