It was reported that the patient¿s ipg is unable to communicate with external devices following an unrelated surgery.Reportedly, the ipg was set to surgery mode prior to the surgery.Troubleshooting was unable to resolve the issue.As such, surgical intervention may take place at a later date to address the issue.
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The reported observation of ¿no 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 due to the patient¿s procedure.Dhr review: the ipg with serial number (b)(6).1 had been manufactured and tested according to the current manufacturing specifications, and passed all manufacturing test and visual inspection requirements.No rework or ncmr associated with this event.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.
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