BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2983502 · Received February 28, 2013

    Report

    Report Number
    1644487-2013-00554
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    October 26, 2009
    Report Date
    February 1, 2013
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF IN HOUSE PROGRAMMING HISTORY, IT WAS FOUND THAT A FAULTED DIAGNOSTIC TEST OCCURRED ON (B)(6) 2009, WHICH SET THE GENERATOR TO UNINTENDED SETTINGS. THE DEVICE WAS PROGRAMMED BACK TO INTENDED SETTINGS; HOWEVER, THE MAGNET MODE WAS NOT PROGRAMMED BACK ON UNTIL THE FOLLOWING VISIT ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87992 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR