BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION)

    MDR report key: 1052002 · Received May 21, 2008

    Report

    Report Number
    6000002-2008-07279
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 2, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, AFTER THE INSERTION, CUSTOMER USED THIS DEVICE WITH EXTERNAL PACEMAKER BUT IT WAS UNABLE TO PACE. SINCE THE PACING WAVE FORM WAS NOT SHOWN, CUSTOMER REMOVED THE DEVICE AND ANOTHER CATHETER WAS USED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION) PACING CATHETER DYG EDWARDS LIFESCIENCES, PR PEK074F5 246K0334

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other