It was reported that the patient had been experiencing whole body shakes since undergoing vns generator replacement surgery.The caregiver suspected these events were seizures which would be a new seizure type for the patient.It was reported that these body shake events do not occur with stimulation.The patient was seen by the physician after the caregiver reported the body shake events to the manufacturer.However the caregiver did not report these events to the physician and the physician was unaware of the body shake events.Therefore, the physician could not determine if these events were seizures and he could not assess their relationship to vns therapy.It was noted during the visit with the physician that diagnostics were ok and that the generator's settings are still being titrated up since implant.Manufacturing records for the generator was reviewed and found that it passed quality control inspection.No additional relevant information has been received to date.
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