BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1880320 · Received October 15, 2010

    Report

    Report Number
    1644487-2010-02327
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE SURGEON THAT THE PT WAS TAKEN INTO SURGERY FOR AN END OF SERVICE BATTERY REPLACEMENT. WHEN HE INTERROGATE THE PT'S DEVICE, HE NOTICED THAT THE PT'S DEVICE SETTINGS WERE ALTERED BY A FAULTY SYSTEM DIAGNOSTICS TEST. THIS LIKELY HAPPENED IN THE TREATING PHYSICIAN'S OFFICE AS HE HAD A FAULTY SYSTEM TEST IN THE OPERATING ROOM. ERI STATUS SAID YES BUT THE SETTINGS WERE NOT THE INTENDED SETTINGS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TILL DATE. THE CAUSE OF THE EVENT IS UNK AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR