The reported observation of ¿inoperable ipg¿ was confirmed.The analysis results concluded the inability to establish communication between the programmer and the implantable pulse generator (ipg) was due to the device entering the service application state.The root cause of the device entering the service application state was related to the patient¿s procedure.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.Per the clinicians manual: per clinicians manual arten600144297a rev.A - under warnings - there is sufficient documentation concerning the use of use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system, and medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).Per the clinicians manual electrosurgery.To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems.Before using an electrosurgery device, place the device in surgery mode using the patient controller app or clinician programmer app.Confirm the neurostimulation system is functioning correctly after the procedure.Manufacturing investigation: plano site: no issue found with dhr review.There was no rework or ncmr associated with this event.
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