BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303

    MDR report key: 3200232 · Received July 1, 2013

    Report

    Report Number
    1644487-2013-01993
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS UNKNOWN; HOWEVER, THIS INFORMATION IS KNOWN AND WAS INADVERTENTLY OMITTED FROM THE PREVIOUSLY SUBMITTED MDR. THIS REPORT IS BEING SUBMITTED TO CORRECT THE AFOREMENTIONED FIELDS.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT REPORTED THAT HE SAW THE PHYSICIAN THAT MORNING AND THE INFECTION WAS GONE. THE PATIENT IS GOING TO KEEP THE INCISION SITE CLEAN AND USE PEROXIDE FOR A COUPLE MORE DAYS. HE WAS TOLD TO GO BACK TO THE PHYSICIAN IF THERE WAS ANOTHER PROBLEM. ON (B)(6) 2013, THE PATIENT REPORTED THAT HE HAD ANOTHER INFECTION IN THE SAME SPOT THAT HE HAD THE INFECTION PREVIOUSLY. THE PATIENT WENT TO SEE THE PHYSICIAN ON (B)(6) 2013 AND THE PHYSICIAN PUT HIM ON MEDICATION FOR 14 DAYS. FOLLOW UP WITH THE PHYSICIAN'S OFFICE CONFIRMED THAT THE INFECTION WAS RELATED TO THE PREVIOUS INFECTION REPORTED AND WAS ON THE STITCH ON THE NECK. THE PATIENT WAS SEEN ON (B)(6) 2013 AND THE PHYSICIAN STATED THAT HE HAD A SMALL STITCH ABSCESS. PER THE NURSE, IT APPEARS THE PATIENT IS NOT TOLERATING THE STITCHES FROM THE SURGERY WELL. THE PHYSICIAN REMOVED THE STITCH AND CAUTERIZED THE SPOT WITH SILVER NITRATE. THE PATIENT WAS GIVEN ANTIBIOTICS AND INSTRUCTED ON WOUND CARE. NO CULTURES WERE TAKEN TO CONFIRM THE EVENT. NO PATIENT MANIPULATION OR TRAUMA OCCURRED WHICH CAUSED OR CONTRIBUTED TO THE INFECTION. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT HE HAD A SMALL BUMP OR POCKET ON THE UPPER LEFT SIDE OF THE INCISION ON HIS NECK THAT APPEARS TO BE FULL OF FLUID. IT WAS DESCRIBED AS SMALL AND ABOUT THE SIZE OF "HALF A PEA." WHEN THE PATIENT MANIPULATES THE AREA, BLOOD COMES OUT. HE CALLED IT A PUS POCKET, BUT SAID THERE IS NO PUS, ONLY BLOOD INSIDE. IT WAS FIRST NOTICED ABOUT FOUR TO FIVE DAYS PRIOR. HE SAID HE THOUGHT IT WAS AN INGROWN HAIR INITIALLY AND THAT HE WOULD SEE THE PHYSICIAN. AFTER SEEING THE PHYSICIAN, THE PATIENT REPORTED THAT THE PHYSICIAN SAID HE HAD AN INFECTION ACROSS THE INCISION SITE WHERE THE DEVICE IS LOCATED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. ADDITIONAL CORRESPONDENCE WITH THE PATIENT FOUND THAT THE AREA AROUND THE INCISION OF THE DEVICE DEVELOPED A ROUND RED CIRCLE ABOUT THE SIZE OF A SILVER DOLLAR ON (B)(6) 2013. THE PATIENT WENT TO THE PHYSICIAN'S OFFICE ON THIS DAY AND WAS DIRECTED TO THE EMERGENCY ROOM TO BE TREATED. HE WAS STARTED ON BACTRIM DS. ON THE NIGHT OF (B)(6) 2013, THE PATIENT STATED THAT PUS STARTED RUNNING OUT OF THE INCISION AREA WHERE THE DEVICE IS LOCATED. THE REDNESS WAS THE SIZE OF A QUARTER AT THIS TIME, WITH THE INCISION SITE AS THE "EQUATOR". THE PATIENT STATED THE INCISION SITE AT THE NECK HAS IMPROVED SINCE THE ANTIBIOTICS WERE STARTED, AND THAT WHAT HE ORIGINALLY THOUGHT WERE INGROWN HAIRS WERE ACTUALLY THE SUTURES. THE SUTURES CAME OUT AND HE SAVED THEM IN A BAG. FOLLOW UP WITH THE NEUROLOGIST'S OFFICE CONFIRMED THAT THE EVENT WAS FIRST OBSERVED ON (B)(6) 2013. IT WAS UNKNOWN IF CULTURES WERE TAKEN TO CONFIRM AN INFECTION; HOWEVER, THE PATIENT WAS SEEN ON (B)(6) 2013 AND IS FINE. THE INCISIONS ALL LOOK FINE AND THE ANTIBIOTICS WERE ONLY PRESCRIBED AS A PRECAUTION. THE PATIENT WAS DESCRIBED AS SOMEONE WHO GETS CONCERNED VERY EASILY, AND THE OFFICE STATED THAT THE AREA APPEARED TO BE HEALING AND THERE WAS NO SIGN OF AN INFECTION. NO PUS OR BLOOD WAS SEEN. IT WAS ADDITIONALLY STATED THAT THERE WAS NO RELATION BETWEEN VNS AND THE REPORTED INFECTION. THE AREA WAS CLEANED WITH BACITRACIN AND PEROXIDE. THERE WERE NO REPORTS OF FEVER. ON (B)(6) 2013, THE PATIENT REPORTED THAT HE MADE AN APPOINTMENT WITH THE SURGEON, BECAUSE HE HAD MORE STITCHES COMING OUT AND THEY WERE NOT DISSOLVING. HE STATED THERE WAS ALSO ANOTHER SPOT WHERE MORE STITCHES APPEAR TO BE COMING OUT. THE PATIENT WAS SEEN BY THE SURGEON ON (B)(6) 2013. FOLLOW UP WITH THE SURGEON ON THE REPORTED EVENTS FOUND THAT ONE OF THE STITCHES HAD A PUS POCKET, BECAUSE IT LOOKED AS IF THE STITCH HAD BECOME INGROWN, AND THAT THIS WAS ALL THAT WAS GOING ON WITH THE PATIENT. IT WAS STATED THAT, OTHERWISE, THE PATIENT LOOKED FINE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298235 LEAD MODEL 303 LEAD LYJ CYBERONICS, INC. 303-30 202407

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other