It was reported that this patient received a generator replacement and did not remove his bandage for 7 days post-surgery and the generator site became infected.Additional information was received that the patient had a three day history of pain and redness.The incision site was red, inflamed and swollen, and therefore the surgeon admitted the patient for removal of the battery.It was stated that the patient's device was explanted due to the infection, which was stated to be mrsa.A review of device history records showed that the implanted generator was sterilized prior to distribution.All other quality tests also passed prior to distribution.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No other relevant information has been received to date.
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Additional information was reported that this patient had other surgeries that were related to their vns explant issue.It was clarified that the patient was seen during a follow-up neurology visit where it was stated that the patient apparently had multiple surgeries after his last vns replacement.He has had 4 surgeries including the initial vns replacement.The patient developed an infection over 3 weeks after the initial surgery.At the surgery, a wound wash out was performed to try and save the implant.When the patient was first taken to the or, the surgeon opened up the incision of the generator and washed everything out because it was looking good after his implant.The patient was taken back to surgery on (b)(6) 2018 and explanted the vns generator.Since that time, the surgeon also explanted the lead as the infection was going up the patient's neck and therefore the lead and clips were removed.It was stated that the patient had mrsa.The lead anchor was seen directly under where a pocket of puss was located.Several non-absorbable sutures were in place and these were removed during the explant surgery.There is a wound on the patient's neck indicating the explant of the lead.It was stated that the patient barely has any voice, and it sounds like a whisper, and therefore is being seen by an ent who said that the patient's vocal cords are paralyzed and therefore the patient needs to undergo a scope.The patient has a lot of discomfort from the surgeries, and the patient is very unhappy about the multiple procedures.It was also stated that the patient is an active smoker which could have contributed to the infection risk.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No other relevant information has been received to date.
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