Clinic notes dated (b)(6) 2015 report that the patient had a motor vehicle accident on (b)(6) 2015.Since that time, he was experiencing regular shocking sensations in his left face with timing consistent with the vns cycling.The shocking sensation was stronger with magnet stimulation.The patient went to the hospital where x-rays were taken which reportedly did not show any abnormalities with the vns system.The patient had an appointment scheduled with the surgeon on (b)(6) 2015.The neurologist performed diagnostics and all diagnostic testing was normal with normal lead impedance.He assessed that there were no apparent problems on electrical testing.The device was turned off, and the patient had no further shocking sensations.So at that time, the device was left programmed off.The plan was to turn it back on to tolerated settings if the surgeon found no problems with no plans for a procedure.Upon follow-up, the surgeon's office upon follow-up that the patient went to the er for the shocking sensation from the motor vehicle accident and then had surgery on (b)(6) 2015 due to the shocking sensation.No additional relevant information has been received to date.
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Operative notes from (b)(6) 2015 were received and reported that the patient had felt random shocks from vns since the motor vehicle accident at the end of (b)(6) 2015.Even when taping the magnet over the generator, the shocking feeling persisted.The neurologist therefore programmed the device off and was referred the patient for explant.The generator was explanted on (b)(6) 2015.The surgeon noted that no abnormalities were noted.The operative notes indicated the device was sent back for analysis, but it was not received.The company representative checked with the hospital, and it was reported the device was discarded.
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