BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 1823429 · Received August 25, 2010

    Report

    Report Number
    1644487-2010-01939
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEY HAD A PATIENT WHOSE VNS TIE DOWN WAS EXTRUDING THROUGH THE SKIN. THE TIE-DOWN WAS LOCATED ABOVE THE COLLAR BONE. THERE WAS NO REPORT OF TRAUMA/MANIPULATION PRIOR TO THE EVENT OCCURRING. THE PATIENT HAD SURGERY AND HAD THEIR VNS TIE DOWN RESECURED AS IT WAS REPORTED TO HAVE COME LOOSE. THE PATIENT'S PROLENE SUTURE WAS REPLACED. AROUND THE SAME TIME AS THEIR PROTRUSION EVENT, THE PATIENT WAS HAVING AN INCREASE IN SEIZURES BEING ATTRIBUTED TO THEIR MEDICATION DILANTIN LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20 2461

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R