BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 3163181 · Received June 11, 2013

    Report

    Report Number
    1644487-2013-01744
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    TYPE OF DEVICE, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY LISTED THE TYPE OF DEVICE NAME INCORRECTLY.

    Description of Event or Problem · 1

    A SURGEON PRESENT DURING A VNS IMPLANTATION CASE REPORTED THAT THE OPERATION WAS UNUSUALLY DIFFICULT FROM THE TECHNICAL PERSPECTIVE AND CONSUMED OVER TWO HOURS OPERATIVE TIME. IT WAS REPORTED THAT THE PATIENT HAD A SHORT FAT NECK, LOTS OF OOZING, ETC. ALSO SHE HAD REPEATED EPISODES OF HYPOTENSION WITH NO APPARENT EXPLANATION. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT AND IS IN GOOD CONDITION. THE CAUSE OF THE PROBLEM WAS NEVER CLEAR BUT IT WAS NOT RELATED TO MANIPULATION OF THE VAGUS NERVE OR TO THE VNS IN ANY WAY. SOMEHOW SHE JUST DID NOT SEEM TO ¿LIKE¿ THE ANESTHETIC. THE ANESTHESIOLOGISTS GAVE VARIOUS MEDS AND MADE SOME ALTERATIONS IN THINGS THEY CONTROL TO STABILIZE THEIR BLOOD PRESSURE. THE PATIENT'S BLOOD PRESSURE WAS IN THE 50'S BRIEFLY. THE PATIENT DID WELL AFTER SURGERY ¿ NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263452 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-30 202328

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R