Clinic notes were received 03/08/2016 for a generator replacement referral.It was reported in the notes for a (b)(6) 2016 visit that the patient was experiencing an increase in seizures (reported in mfr report#1644487-2016-01813).An estimate of battery life was requested by the physician, which estimated that on (b)(6) /2015 there was 0.5 years remaining until the battery life indicator would be flagged and was likely depleted at the time of the events.It was clarified in the notes dated 03/30/2016 that when his vns was checked at his last visit, it was found to be non-functioning.The physician indicated it will need to be replaced asap to improve seizure control.Generator replacement surgery occurred on (b)(6) 2016.The company representative who attended the case was able to interrogate the generator and the battery status indicator was neos=no.The explanted generator was reported to have been discarded by the facility.Additional relevant information has not been received to-date.
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