On (b)(6) 2015 it was reported that the patient has a neck incision complaint and that the patient is seeing the surgeon on (b)(6) 2015.The physician¿s office reported that the ¿neck incision complaint¿ was an infection at the neck site; there was some bruising or hematoma and slight swelling and discoloration.The nurse said that it was from the vns surgery.They decided to wait to turn the vns on since the patient was having the infection.They did not do cultures; they just prescribed the patient antibiotics.They are not going to do any other interventions besides the antibiotics.They saw the patient again recently on (b)(6) 2015 and she was much better, the bruising had gone down, and they decided to turn the vns on.The manufacturing records for both the lead and generator were reviewed and it was confirmed that the devices were sterilized prior to shipment.
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