It was reported that the patient's ipg was not communicating with external devices.Troubleshooting was unable to resolve the issue.It is unknown when the ipg became inoperable.As such, surgical intervention took place where in the ipg was explanted and replaced with a new ipg addressing the issue.Reportedly, therapy was restored post op.
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The reported event for inoperable ipg was confirmed.As received, the ipg was inoperable due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The ipg was functionally tested and passed all testing.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.
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