It was reported that the patient had picked at the neck incision site and pulled out the leads.Patient managed to pick open his neck incision and was seen on (b)(6) 2015.The physician was able to see some of suture underneath the and determined it best to explant the device as patient might end up pulling out a portion of the vns with a risk of infection.Patient underwent full explant on (b)(6) 2015.Additional information was received that the patient previously picked the chest incision site causing wound dehiscence.This is reported in manufacturer report # 1644487-2015-04803.
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