BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2684992 · Received August 7, 2012

    Report

    Report Number
    1644487-2012-01959
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    July 10, 2012
    Report Date
    July 10, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT'S VNS MAGNET MODE SETTING WAS NOTED TO BE SET TO 0MA AND WAS MEANT TO BE SET TO 0.5MA. THE MAGNET SETTING WAS CORRECTED BY THE REPORTER. ATTEMPTS FOR THE PATIENT'S VNS PROGRAMMING HISTORY TO ESTABLISH IF A PROGRAMMING ANOMALY OCCURRED ARE IN PROGRESS.

    Description of Event or Problem · 1

    ALL FURTHER ATTEMPTS TO THE REPORTER FOR VNS PROGRAMMING HISTORY HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR