BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEMNOS 04

    MDR report key: 214983 · Received February 13, 1999

    Report

    Report Number
    1028232-1999-00001
    Event Type
    Other
    Date Received
    February 13, 1999
    Date of Event
    January 5, 1999
    Report Date
    February 7, 1999
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOT PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMNOS 04 Implant PACEMAKER DXY BIOTRONIK, INC. GEMNOS 04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other