BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 297676 · Received September 22, 2000

    Report

    Report Number
    2953184-2000-00002
    Event Type
    Death
    Date Received
    September 22, 2000
    Date of Event
    August 27, 2000
    Report Date
    September 22, 2000
    Manufacturer
    RADIOTHERAPEUTICS CORP
    Product Code
    JOS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEVEN SEPARATE LIVER TUMORS WERE ABLATED WITH RADIOFREQUENCY ENERGY AND AN 8TH TUMOR WAS WEDGE RESECTED IN A PT. THE PT HAD 2 PREVIOUS RESECTIONS AND THEN A LIVER TRANSPLANT PRIOR TO THIS OPERATION. THE PT DID NOT DISPLAY ANY PROBLEMS IMMEDIATLY FOLLOWING THE OPERATION, BUT DEVELOPED LIVER FAILURE A FEW DAYS AFTERWARDS. THE PT SUBSEQUENTLY WAS DISCOVERED TO HAVE SEPSIS AND DIED A FEW DAYS AFTER THE OPERATIONS. THE SURGEON STATED THAT HEPATIC ARTERY THROMBOSIS WAS THOUGHT TO BE THE CAUSE OF DEATH AND THAT A TRANSPLANTED LIVER FROM A LIVING DONOR IS MORE LIKELY TO DEVELOP ARTERY THROMBOSIS AND MORE LIKELY TO SUFFER SERIOUS INJURY AS A RESULT OF THE THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL DEVICE JOS RADIOTHERAPEUTICS CORP LE415 032700

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death THESIA DURING THE PROCEDURE.| NONE REPORTED BUT PATIENT WAS UNDER GENERAL ANES-