BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RITA MEDICAL SYSTEMS, INC, GENERATOR & INTELLIFLOW

    MDR report key: 1310524 · Received February 9, 2009

    Report

    Report Number
    MW5009920
    Event Type
    Injury
    Date Received
    February 9, 2009
    Date of Event
    December 11, 2008
    Report Date
    February 9, 2009
    Manufacturer
    RITA MEDICAL SYSTEMS INTELLIFLOW
    Product Code
    GXD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A RITA MEDICAL SYSTEMS GENERATOR, AND INTELLIFLOW INFUSION PUMP WAS USED TO PROVIDE PALLIATIVE TREATMENT OF A PAINFUL METASTATIC TUMOR ON A BONE. THE FAMILY REPORTED THE PATIENT WAS UNDERGOING OUTPATIENT TREATMENT AT A LOCAL BURN CENTER FOR BURNS SUSTAINED ON THE HEEL AND THIGH, AT THE SITE OF ABLATION AND THE GROUNDING PAD. THE PROCEDURE WAS A SUCCESS IN THAT THE PATIENT EXPERIENCED IMPROVED MOBILITY AND ALLEVIATION OF THE BONE PAIN FROM THE TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITA MEDICAL SYSTEMS, INC, GENERATOR & INTELLIFLOW RITA MEDICAL SYSTEMS, INC, GENERATOR & INTELLIFLOW GXD RITA MEDICAL SYSTEMS INTELLIFLOW RITA 1500X PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other GROUND PADS WERE NOT RETAINED