BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1963685 · Received December 21, 2010

    Report

    Report Number
    1644487-2010-02858
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    October 9, 2003
    Report Date
    November 23, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    DURING A REVIEW OF A PT'S PROGRAMMING HISTORY AS PART OF A REQUEST FOR A BATTERY LIFE CALCULATION, IT WAS IDENTIFIED THAT A FAULTED SYSTEMS DIAGNOSTIC TEST OCCURRED RESULTING IN AN INADVERTENT SETTING CHANGE. THE PT'S SETTINGS WERE NOT CORRECTED UNTIL A F/U APPT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR