Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that on (b)(6), patient fell face forward and got a cut on the head.Patient could not speak words, only sounds.Patient went to the emergency room, they did many tests and could not find anything.Caller stated it had to be a transient ischemic attack (tia) but needed to do an mri to confirm.Patient was able to speak again by 4-5pm that day.Caller was requesting for mri compatibility guidelines.Additional information was received from the patient indicating that it was unknown if the tia was related to the device/therapy and nor could anyone tell them definitely which was upsetting.Patient also noted that for fear of recurrence and if not truly convinced that the device did not contribute to the episode.It was reported that on (b)(6) 2018, the patient was worked on at the hospital to address their increasing resting tremor, and finally settled on going from 4.7 voltage to 5.2, the frequency was also adjusted but the figure was unknown.On (b)(6), the patient was severely disoriented, dizzy and unable to comprehend questions, continually fell asleep, further stating that patient went to bed at 8:00 and slept for 10 hours, awoke seemingly okay, yet a bit shaky.There was no dizziness or disorientation, yet extra fatigue for several weeks.On (b)(6), the patient fell face forward on cement, tripping over a curb, and had head cuts , arm and knee cuts.On (b)(6), the patient seemed fine until early afternoon when completely suddenly could not speak anything but gibberish, was wildly frightened and upset.It was noted that the doctor could not tell if the device changes or just the device without the recent changes could have in any way been a factor in the episode of inability to speak.The doctor at the hospital stated that the voltage and/or frequency changes could not have caused the problem.Patient called the manufacturer's representative (rep) who was not absolutely sure if there could be a connection but did not think so.The hospital ran two head ct scans without contrast 24 hours apart to compare them.No further patient complications were reported/ anticipated as a result of this event.
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