BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 1191907 · Received October 1, 2008

    Report

    Report Number
    1644487-2008-02159
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT HAD HIGH IMPEDANCE RESULTS FROM BOTH THE SYSTEM AND NORMAL DIAGNOSTICS. PER REPORTER, PT DOES NOT HAVE ANY ADVERSE EVENTS AND STILL FEELS STIMULATION. THERE WAS ALSO NO TRAUMA OR MANIPULATION REPORTED. SINCE PT IS STILL DOING SO WELL, DOCTOR DID NOT WANT TO TURN THE DEVICE OFF, SO HE JUST LOWERED THE SETTINGS. ALL ATTEMPTS FOR INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    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