BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1172196 · Received September 11, 2008

    Report

    Report Number
    1644487-2008-02219
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    January 1, 1998
    Report Date
    August 14, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. MURPHY JV, HORNING GW, SCHALLERT GS, TILTON CL. ADVERSE EVENTS IN CHILDREN RECEIVING INTERMITTENT LEFT VAGAL NERVE STIMULATION. PEDIATR NEUROL 1998; 19(JULY):42-4.

    Description of Event or Problem · 1

    IN REVIEW OF AN ARTICLE, IT WAS REPORTED THAT A VNS PATIENT EXPERIENCED A LEAD FRACTURE NOT ASSOCIATED WITH ANY KNOWN TRAUMA. THE FRACTURE WAS DISCOVERED ON AN X-RAY WHEN THE DEVICE STARTED TO FAIL. THE LEAD WAS REVISED UNDER GENERAL ANESTHESIA WITHOUT ADVERSITY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNKNOWN NONE LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR