BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2233243 · Received September 2, 2011

    Report

    Report Number
    1644487-2011-02065
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    March 18, 2010
    Report Date
    August 12, 2011
    Manufacturer
    CYBERONICS
    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

    Description of Event or Problem · 1

    DURING MANUFACTURER REVIEW OF A PATIENT'S VNS PROGRAMMING HISTORY, IT WAS NOTED A FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED ON (B)(6) 2010 WHICH CAUSED THE PATIENT'S SETTING TO CHANGE. THE SETTING CHANGE WAS NOTED UPON REINTERROGATION OF THE VNS, BUT ONLY THE OUTPUT CURRENT WAS CORRECTED. THE OFF TIME WAS LEFT AT 60 MINUTES. THE SETTINGS WERE NOT CORRECTED UNTIL ON OR BEFORE (B)(6) 2010 PER THE HISTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR