It was reported that the patient's ipg stopped communicating with external devices following an unrelated surgery.A manufacturer representative met with the patient and confirmed the ipg to be inoperable.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced.Post-operatively, stimulation therapy was restored.
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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.The reported observation of ¿no ipg communication¿ 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 (b)(6) 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.
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