The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications and released back to the customer.There were no existing capa¿s listed for any of the parts listed in this file for repair.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 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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