It was reported that the patient was having vns explanted due to incision on his chest breaking open, exposing the vns.The patient continues to pick at the incision site.The patient is autistic and requires 24 hour supervision.The physician plans to explant the lead as well due to risk of infection.The patient¿s vns generator was recently implanted.Device history record for the generator and lead showed that both devices were hp sterilized prior to distribution into the field.The devices were explanted.It was noted that the generator was exposed, system was removed, cultures were taken and revealed (b)(6) post-op and the patient was put on antibiotics.No additional relevant information has been received to date.
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