BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIOS D

    MDR report key: 649359 · Received December 2, 2005

    Report

    Report Number
    1028232-2005-00187
    Event Type
    Other
    Date Received
    December 2, 2005
    Date of Event
    August 26, 2005
    Report Date
    November 29, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SWITCHING THE PM: AXIOS D, THE PM IN USE, IS RUNNING FROM THE BEGINNING IN VVI MODE, RATE 62 PPM MAGNETIC RATE 80 PPM, PERMANENT VOO. THE PM CAN NEITHER BE INTERROGATED NOR PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOS D PACEMAKER DXY BIOTRONIK GMBH AND CO., 338843 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention