BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2254154 · Received September 19, 2011

    Report

    Report Number
    1644487-2011-02213
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 15, 2011
    Manufacturer
    CYBERONICS
    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

    REPORTER INDICATED A VNS PATIENT WAS INTERROGATED AND FOUND TO BE AT UNINTENDED SETTINGS OF 0MA/20HZ/500 PULSEWIDTH/30 SEC ON/60 MIN OFF. THESE SETTINGS ARE INDICATIVE OF A PREVIOUS FAULTED SYSTEMS DIAGNOSTICS TEST. THE VNS SETTINGS WERE ADJUSTED AT THIS VISIT. THE REPORTER HAD NOT SEEN THE PATIENT IN OVER 5 YEARS. MANUFACTURER REVIEW OF AVAILABLE VNS PROGRAMMING HISTORY FOR THE PATIENT REVEALED THE LAST KNOWN DATE IN THE HISTORY WAS (B)(6) 2008, AND THE VNS WAS PROGRAMMED TO DELIVER THERAPY AT THAT TIME. IT IS SUSPECTED A PREVIOUS FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED BETWEEN (B)(6) 2008 AND (B)(6) 2011 WITH AN UNKNOWN PROGRAMMING SYSTEM THAT CAUSED THE SETTINGS TO CHANGE.

    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 40 YR