It was reported the patient underwent a non-related surgical procedure wherein the ipg was not placed into surgery mode prior to the procedure.In turn, the patient's ipg was unable to communicate with external devices and the patient lost therapy.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.As a result, surgical intervention occurred wherein the ipg was explanted and replaced to address the issue.
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Date of event is estimated.During processing of this complaint, attempts were made to obtain patient weight, and but it was not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.
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