BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSITE MULTI-ELECTRODE ARRAY CATHETER

    MDR report key: 1080871 · Received July 24, 2008

    Report

    Report Number
    2184149-2008-00009
    Event Type
    Death
    Date Received
    July 24, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ST. JUDE MEDICAL, ESI
    Product Code
    DRF
    PMA / PMN Number
    K983456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL IS IN THE PROCESS OF INVESTIGATING THIS EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED AS THE ENSITE ARRAY CATHETER WAS BEING INSERTED INTO THE RIGHT VENTRICLE, IT WAS NOTICED THAT THE PT'S BLOOD PRESSURE WAS LOW. A TAMPONADE OCCURRED AND THE PHYSICIAN WAS UNABLE TO KEEP THE BLOOD PRESSURE AT NORMAL LEVELS AND KEEP THE HEART CONTRACTING. THE PT EXPIRED ON THE OPERATING TABLE. THE DEVICE IS CURRENTLY BEING HELD BY THE CORONER FOR INVESTIGATION AND IS NOT AVAILABLE FOR ANALYSIS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE MULTI-ELECTRODE ARRAY CATHETER ARRAY CATHETER DRF ST. JUDE MEDICAL, ESI NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death