It was reported by a patient that he had experienced "irregular stimulation" and painful stimulation with his vns device.The patient reported that the generator (unknown when implanted and reportedly explanted in (b)(6) 2016) caused him to have painful stimulation in the left neck and armpit, and the "irregular stimulation" to his vagus nerve caused his body to "forget how to breathe" while sleeping.The patient also reported that he had to then start using oxygen at night to make sure his body continues to breathe while he sleeps.Reportedly, the neurologist informed the patient that the irregular stimulation from the generator caused his nerve to become dependent on the stimulation to remember to breathe, so the neurologist continues to suggest that the patient be re-implanted with vns.However, the patient refused to be re-implanted after the third generator was explanted.The patient kept the third generator after explant, and the lead was left implanted.The patient also reported that vns did help reduce his seizures, but he has stress-induced grand mal seizures which were exacerbated by the painful stimulation and distress over having "defective vns devices." he tried to hurt himself as well because of the painful stimulation and distress.No further relevant information has been received to date.
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