BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 1243201 · Received November 10, 2008

    Report

    Report Number
    6000002-2008-09233
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 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 INSERTED IN THE MORNING. THERE WAS NO PROBLEM IN THE MORNING, BUT IN THE AFTERNOON, IT BECAME UNABLE TO PACE. ANOTHER CATHETER WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other