It was reported that the vns patient developed an infection at the generator site following initial implant surgery on (b)(6) 2013.The infection was first noted on (b)(6) 2013 and the patient underwent surgery on (b)(6) 2013 to explant the generator and a portion of the lead.The patient was subsequently treated for the infection and underwent surgery on (b)(6) 2015 to explant the remaining portion of the lead and re-implant a new system.It was reported that surgical technique was the believed cause of the infection.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
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