BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEEN SUPERSLIM ELECTRODE

    MDR report key: 537791 · Received August 5, 2004

    Report

    Report Number
    6000037-2004-00030
    Event Type
    Death
    Date Received
    August 5, 2004
    Date of Event
    June 17, 2004
    Report Date
    July 7, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LEVEEN ELECTRODE WAS BEING USED ALONG WITH AN RF GENERATOR FOR THE THERAPEUTIC ABLATION OF TWO 2.5 CENTIMETER TUMORS IN THE LIVER. DURING THE PROCEDURE, THE PT BEGAN EXPERIENCING ACUTE PAIN AT THE BOSOM AND ABDOMEN EVEN THOUGH MIDAZOLAM HAD BEEN INFUSED AT THE BEGINNING OF PUNCTURE THROUGH THE VEIN. ALTHOUGH CLOTTING PARAMETERS WERE NORMAL PRIOR TO THE PROCEDURE AND NO BLEEDING FROM THE PUNCTURE POINT WAS FOUND, THE NEXT DAY THE PT EXPERIENCED HEMORRHAGING IN THE LUNGS AND SUBSEQUENTLY EXPIRED. NO AUTOPSY WAS PERFORMED TO DETERMINE THE PRIMARY SITE OF BLEED. IT SHOULD ALSO BE NOTED THAT THE PHYSICIAN BELIEVED THE NEEDLE DID NOT PUNCTURE THE LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN SUPERSLIM ELECTRODE ELECTRODE JOS BOSTON SCIENTIFIC NA 120103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death