It was originally reported that the patient was experiencing pain at the incision site.Reported that the patient presented with what appeared to be an infection over the generator site.It was stated to be red and hot to the touch.The patient had a 102 degree fahrenheit fever.There were no other discomforts or pain associated with stimulation.Lab work was performed and confirmed that the patient had a bacterial infection.The patient was prescribed vancomycin and zosyn.A review of device history records was performed revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution.It was later reported that the patient underwent vns explantation surgery due to the infection.No additional relevant information has been received to date.
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