It was reported that a patient who is subject to a (b)(6)study had the vns neck site red with a visible area of puss present.The severity of the event was moderate.It was reported that the event was unlikely related to study therapy, not related to implant nor to vns stimulation.It was reported that the treatment was not changed but the medication was added.It was reported that the patient is recovering.The event was not indicated as a serious adverse event.Additional information indicated that this adverse event could be related to a "septic arthritis", which occurred after a motorcycle accident the patient had on (b)(6) 2016.Review of manufacturing records confirmed sterilization for the lead prior to distribution.The vns patient's device was tested on 06/05/2016 and system diagnostics returned impedance results within normal limits with 3821 ohms.
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