BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2181244 · Received July 8, 2011

    Report

    Report Number
    1644487-2011-01533
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT UNUSUAL RESULTS WERE OBTAINED WHEN PERFORMING SYSTEMS DIAGNOSTICS TESTING FOR A VNS PT. NORMAL MODE DIAGNOSTICS YIELDED NORMAL RESULTS. VNS INTERROGATION PRIOR TO AND AFTER ALL DIAGNOSTICS WERE PERFORMED INDICATED THE SETTINGS WERE AS INTENDED. THE REPORTER DID NOT FEEL ANY LOSS OF THERAPY WAS OCCURRING FOR THE PT. ATTEMPTS FOR PROGRAMMING HISTORY ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR