BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1890157 · Received October 22, 2010

    Report

    Report Number
    1644487-2010-02389
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    August 31, 2004
    Report Date
    September 30, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING/DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    DURING ANALYSIS OF THE PT'S PROGRAMMING/DEVICE DIAGNOSTIC HISTORY, IT WAS FOUND THAT A FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED WHICH CHANGED THE PT'S SETTINGS. A FINAL INTERROGATION WAS NOT PERFORMED TO ENSURE THE SETTINGS WERE CORRECT AND THE SETTING CHANGE WAS NOT OBSERVED/ADDRESSED UNTIL A SUBSEQUENT OFFICE VISIT. THERE WERE NO REPORTS OF ANY PT ADVERSE EVENTS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 162256

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR