BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3222356 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02080
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    November 17, 2006
    Report Date
    June 18, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE REVEALED THAT THE INITIAL INTERROGATION ON (B)(6) 2006 SHOWED SETTINGS THAT WERE INDICATIVE OF A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRING WHICH LIKELY CHANGED THE DEVICE TO UNINTENDED PARAMETERS. THERE IS NO HISTORY AVAILABLE FROM THE DATE OF IMPLANT, (B)(6) 2006. HOWEVER, IT WAS REPORTED AT THAT TIME THAT THE SURGEON WAS RECEIVING ERROR MESSAGE WHEN ATTEMPTING TO PERFORM DIAGNOSTIC TESTING ON THE DATE OF IMPLANT. TROUBLESHOOTING WAS PERFORMED AT THAT TIME BUT DID NOT RESOLVE THE EVENT. THEREFORE, IT IS LIKELY THAT A COMMUNICATION ISSUE RESULTED IN ONLY PARTIAL COMPLETION OF THE DIAGNOSTIC TEST WHICH CHANGED THE PATIENT'S SETTINGS. THE SURGEON WAS ABLE TO SUCCESSFULLY INTERROGATE THE DEVICE. IT IS RECOMMENDED IN MANUFACTURER LABELING TO PERFORM A FINAL INTERROGATION TO ENSURE THE DEVICE IS AT INTENDED PARAMETERS. THE DEVICE WAS THEN TURNED OFF ON (B)(6) 2006 AND PROGRAMMED ON (B)(6) 2006. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323319 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 366982

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR