It was reported that the recently implanted vns patient developed an infection.During the post-operative period, the patient picked at the generator site and the incision opened.The incision site was re-closed, covered, and healed so the sutures were later removed.During the weekend of (b)(6) 2015, the patient went to the er as she had picked at the generator site and reopened the incision.The lead incision site had healed well; however, the generator incision site was partially opened and the patient¿s generator was exposed.Wound cultures were (b)(6).The patient underwent surgery on (b)(6) 2015 to explant the generator and lead.During the procedure, it was noted that dense scar tissue surrounding the patient¿s nerve.The scar tissue was lysed and the electrodes were able to be removed.The patient has not been re-implanted to date.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
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