A patient reported to their physician that he could no longer feel the vns activating.The physician increased the normal output current stimulation from 2.00ma up to 2.25ma.The patient had an adverse reaction to this increase causing him to cough and choke.The physician then reduced settings until the patient could tolerate them.The patient later reported on a follow-up visit on (b)(6) 2015 that he had previously experienced a fall and chest trauma and that he could feel the vns activating at the generator site.Normal mode diagnostics indicated an impedance reading of lead impedance=ok, dcdc=0, near end of service=no.The physician suspected the lead had a short circuit based on the dcdc value of 0, although this result was on normal mode diagnostics rather than systems diagnostics.The device was disabled on (b)(6) 2015, and it was indicated that the patient wants to try medicine alone.X-rays were ordered by the physician, but have not been received by the manufacturer for review.A review of the available programming history in the manufacturer's database showed the last normal mode diagnostics on (b)(6) 2014 to have an impedance value of dcdc=4.Additional relevant information has not been received to-date.
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Follow-up to the physician¿s office revealed that the patient had gained 15 kilograms since deactivation of vns.It was reported that the patient was programmed to 0.75ma, which was where the coughing and choking stopped, prior to the device being disabled.There had been no change in quantity of seizures or stability since the device was disabled.The patient¿s family was anxious to remove the device as it was believed the device is no longer needed.The weight gain was considered positive for the patient.An increase in cognition was reported since the device was disabled.The x-rays taken did not show any device issue.Diagnostics were performed with the patient in multiple positions to rule out an issue related to the position of the device and the diagnostics were reported to be the same in multiple positions.No known surgery has occurred to-date.
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