BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNK

    MDR report key: 1953644 · Received January 4, 2011

    Report

    Report Number
    1644487-2011-02963
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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

    REPORTER INDICATED A VNS PATIENT WAS HOSPITALIZED DUE TO HAVING PAINFUL STIMULATION IN THE NECK. NO KNOWN TRAUMA OCCURRED. THE PATIENT WAS HOSPITALIZED TO PRECLUDE A SERIOUS INJURY PER THE REPORTER. THE VNS WAS DISABLED, BUT THE PATIENT CONTINUED TO REPORT, SHE FELT PAINFUL STIMULATION AND WAS OBSERVED TO HAVE VOICE ALTERATION WITH THE REPORTED STIMULATION. THE PATIENT HAD THE VNS SETTINGS INCREASED SLIGHTLY THREE DAYS PRIOR TO THE PAINFUL STIMULATION OCCURRING. THE PATIENT LATER HAD GENERATOR REPLACEMENT SURGERY ONLY DUE TO THE PAINFUL STIMULATION; THE ORIGINAL LEAD WAS NOT REPLACED. SINCE THE SURGERY, THE PATIENT'S NEW VNS GENERATOR HAS BEEN TURNED ON AND THE PATIENT IS NO LONGER EXPERIENCING ANY PAINFUL STIMULATION. ATTEMPTS FOR RETURN OF THE EXPLANTED GENERATOR ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R