BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2990900 · Received March 6, 2013

    Report

    Report Number
    1644487-2013-00597
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    October 13, 2008
    Report Date
    February 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY PERFORMED.

    Description of Event or Problem · 1

    VNS PROGRAMMING HISTORY FOR THE PATIENT'S DEVICE WAS REVIEWED ON (B)(6) 2013. IN REVIEWING THE DATA, IT WAS OBSERVED THAT ON (B)(6) 2008 THE DEVICE WAS FOUND TO BE AT UNINTENDED SETTINGS, WHICH WOULD HAVE RESULTED FROM AN INTERRUPTED SYSTEM DIAGNOSTIC TEST AT A PRIOR DOSING SESSION. ACCORDING TO THE PROGRAMMING HISTORY, THE PRIOR DOSING SESSION OCCURRED ON (B)(6) 2008, WHICH IS WHEN THE VNS DEVICE SETTINGS WOULD HAD CHANGED TO UNINTENDED SETTINGS. THE SETTINGS WERE NOT FOUND OR CORRECTED UNTIL (B)(6) 2008. THERE WERE NO REPORTS OF ANY PATIENT ADVERSE EVENTS AS A RESULT OF THE SETTING CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95166 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521411

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR