BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER

    MDR report key: 1172365 · Received September 19, 2008

    Report

    Report Number
    6000002-2008-08701
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 1, 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

    IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO PACE FROM THE BEGINNING. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER PACING CATHETER DYG EDWARDS LIFESCIENCES, PR PE074F5 58501915

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other