BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 624294 · Received August 3, 2005

    Report

    Report Number
    1644487-2005-00510
    Event Type
    Malfunction
    Date Received
    August 3, 2005
    Report Date
    July 6, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S OUTPUT CURRENT HAD CHANGED TO 0MA WITHOUT THE DEVICE BEING PROGRAMMED TO THIS PARAMETER. DEVICE INTERROGATED IS REPORTEDLY PERFORMED AFTER EVERY PROGRAM CHANGE TO ENSURE THAT THE DEVICE IS SET APPROPRIATELY. THE CAUSE OF THE EVENT IS UNKNOWN AS THIS EVENT IS CURRENTLY UNDER INVESTIGATION. THE TREATING NEUROLOGIST'S NURSE WOULD NOT PROVIDE PATIENT IDENTITY AT TIME OF THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO