Model Number 106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930)
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Event Date 10/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
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Event Description
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It was reported that the patient reported to the clinic with a fever and cellulitis around the vns generator site.A culture was taken.A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution.Clinic notes were later received from the surgeon.The notes indicated that the lab results form the cultures were moderate staphylococcus aureus.It was reported that the wound was much better and the erythema was essentially completely resolved.It was stated that there was still an open area and the lower part of the incision needed to be packed.The surgical notes included in the clinic notes indicated that the lead incision site was re-opened by the surgeon.No purulence or infection was observed.The incision was irrigated with gu irrigant and antibiotics were placed in the wound.The incision was closed.The generator incision was re-opened by the physician and purulent material was encountered in the pocket.The generator was removed and the portion of the lead in continuity with the generator was removed.The generator pocket was lavaged and then instilled with antibiotic irrigation.The incision was closed except for the caudal centimeter and a half of the incision, which was left open and packed with antiseptic soaked gauze.Sterile dressing was placed about the incision.No additional relevant information has been received to date.
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Event Description
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It was reported that the patient under surgery to explant the vns electrodes, which were the only portion of the lead remaining implanted, due to the cultures coming back as (b)(6).
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Search Alerts/Recalls
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