BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

    MDR report key: 1920260 · Received December 10, 2010

    Report

    Report Number
    2015691-2010-14515
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED DUE TO THE DEVICE BEING EXPOSED TO AN INFECTIOUS DISEASE. WITHOUT THE RETURN OF THE DEVICE, THE COMPLAINT CANNOT BE CONFIRMED NOR COULD ANY POTENTIAL CONTRIBUTING FACTORS BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO PACE DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE075F5

    Patients

    Seq Age Sex Outcome Treatment
    1