BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 102

    MDR report key: 1232725 · Received November 14, 2008

    Report

    Report Number
    1644487-2008-02763
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS THERAPY PATIENT PRESENTED WITH HIGH IMPEDANCE ON BOTH SYSTEM AND NORMAL MODE DIAGNOSTIC TESTS. THE DEVICE WAS DISABLED AND THE PATIENT HAS BEEN REFERRED TO A SURGEON. THE PATIENT DENIED ANY TRAUMA OR FALLS, BUT DID STATE THAT SOMETIME AGO, SHE FELT SOMETHING WAS STICKING OUT SO SHE PUSHED IT BACK. HOWEVER, THE PHYSICIAN COULD NOT SEE ANYTHING STICKING OUT OR LOOKING ABNORMAL. 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 102 MUZ CYBERONICS, INC. 302-20 1283

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female