It was reported that the vns patient may have developed an infection at the generator site and was given antibiotics.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.Follow-up revealed that there was no infection that developed but the generator incision site had swelling where a suture was located.It was reported that the surgeon revised the incision site because "it was not up to his standards" and he was not satisfied with how the incision appeared.The majority of the sutures had already disappeared except for one at the swollen area.The patient underwent surgery on (b)(6) 2016 to clean and revise the incision site to prevent the potential of an infection occurring.
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