Information was received from the consumer via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that patient was done under general anesthesia.To identify lead positions, collision studies were done and left and right to determine bilateral coverage of each lead.After collision studies and battery was be being implanted, impedance reading were attempted but the controller and communication had locked up.Manufacture was contacted to determine the communicator needed to be recycled to reset communication.After 2 attempts were done they were successful and impedance determined to be within normal limits.The device was not further interrogated ad per normal protocol, since it was felt the device was shut off.The next day the hcp to contact patient.It was determined that the device was left on high amplitude causing patient great discomfort till he was able to grab his communicator and discontinue stimulation.Factors that may have led or contributed to the issue is either the lock up prevented the return of the 8-15 channel from returning to 0, as rep felt he returned it to 0.Or it was operator error and was not returned at all.However, it seemed that was the last thing rep did to noting the lock up was returned to 0, but one way or the other the device was left on causing the patient discomfort till he could turn it off.Patient was contacted and will be seen for post off soon.The issue was resolved at the time of this report.No surgical intervention occurred or planned.Additional information was received from the patient.Patient started the was "shocked to death for 10 hours" they put the stimulator in and when patient woke up it was shocking them and patient is convulsing and shaking back and forth and it hurt so bad they could not even go to the bathroom.Patient eventually turned stimulation off last night from this report and the shocking stopped as soon as they turned it off.Patient said that the rep was not there when this started and the hcp told them not to turn it on for 2 weeks, but patient says that when he woke up from surgery the stimulation level was all the way up and the patient was shaking like crazy.Patient stated they said it was normal.Patient was advised to follow up with health care professional (hcp).No further patient sympto ms or complications were reported in this event.
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