BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2820453 · Received November 6, 2012

    Report

    Report Number
    1644487-2012-02900
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    April 18, 2007
    Report Date
    October 15, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2012 DURING REVIEW OF THE PATIENT'S PROGRAMMING HISTORY IT WAS NOTED THAT ON (B)(6) 2007 A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED THAT CHANGED THE PATIENT'S SETTINGS TO NON-EFFICACIOUS OFF TIME OF 60MIN. THESE SETTINGS WERE NOT CORRECTED UNTIL THE PATIENT'S VISIT ON (B)(6) 2007. NO ADVERSE EVENTS HAVE BEEN REPORTED THAT WERE CAUSED BY THIS SETTINGS CHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR