An inoperable ipg/ high impedance was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.As a result, the patient¿s ipg was explanted and replaced.Therapy was restored.The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with user error.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on (b)(6) 2017.
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