It was reported that the patient underwent vns replacement surgery and that one week post-op, the patient's incision sites looked good.However, a few days later, the patient reported a sudden swelling at the generator site and presented to urgent care, where bactrim was prescribed.The patient then followed up with the implanting surgeon.An incision was made to release drainage and the patient was prescribed cefzil.It was determined that the hematoma needed further treatment and needed to be cleaned out in surgery.The patient underwent surgery to address the hematoma.Upon opening the chest, the surgeon noted pus inside of the lead.It was stated that the surgeon saw "yellow and green" on the lead.It was reported that the impedance values were ok.The surgeon was not comfortable with opening the neck due to the infection.The surgeon planned on removing the generator and a portion of the lead, then tying it down, and waiting for the infection to clear.When attempting to remove a portion of the lead, it was found that a section of the lead further up from the generator appeared to have an opening and they were able to "push stuff out of it".The abraded opening and fluid inside the tubing was reported in mfr.Report #1644487-2019-01885.A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution.The lead was implanted approximately six years prior and, therefore, the sterility of the device post-manufacturing is not relevant.No additional relevant information has been received to date.
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