BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4061492 · Received September 4, 2014

    Report

    Report Number
    1644487-2014-02227
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    September 8, 2005
    Report Date
    August 8, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THE INCORRECT INITIAL REPORTER. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING HISTORY IT WAS NOTED THAT AN INCOMPLETE DIAGNOSTICS OCCURRED WHICH CHANGE THE PATIENT TO UNINTENTIONAL SETTINGS. THERE WAS NO FINAL INTERROGATION AND THE PATIENT LEFT AT UNINTENTIONAL SETTING. THE SETTINGS WERE CORRECTED AT LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542934 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 366975

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR