Follow-up was performed with the patient¿s neurologist.He was informed that product analysis found lead fractures and high impedance.He was not aware of any high impedance.System diagnostics were always within normal limits to his knowledge.The patient¿s mother was adamant that the device was not helping, but he did not agree.He programmed the device off in november 2014 and left the magnet on.At that time the impedance was 3980 ohms.The patient had a lower seizure frequency about a year after implant.He disabled the device in (b)(6) 2014 to prepare for explant in 2015 as requested by the patient¿s mother.His protocol is to leave the device off for 6 months to determine whether vns is actually helping the patient.Within 6 months of disabling the device, the patient started to experience drop seizures, which he has never had before.The neurologist maintained that vns was clearly helping the patient as the patient did not have a new seizure type in 14 years until vns was programmed off.He did not think the patient hitting himself was in any way related to the high impedance which was found, as the patient was hitting himself as soon as the device was implanted.
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