BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1670597 · Received April 26, 2010

    Report

    Report Number
    MW5015711
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B) (6) FEMALE UNDERWENT A CT IMAGING GUIDANCE RADIOFREQUENCY ABLATION OF THE LIVER UTILIZING A BOSTON SCIENTIFIC MODEL RF 3000 ABLATION UNIT. GROUNDING PADS APPLIED TO UPPER THIGH TO THE INNER AND OUTER ASPECT OF THIGHS. STUDY PERFORMED WITH GENERAL ANESTHESIA. AFTER PROCEDURE AND PT AWAKE, THE PT COMPLAINED OF BURNING PAIN TO THE LEFT THIGH. WHEN EXAMINED A 10 CM RAISED AREA WITH A 6 CM BURN WAS PRESENT IN THE RAISED AREA WHERE THE GROUNDING PAD WAS APPLIED. AN ARNP ASSESSED THE PT AND BURN WAS DETERMINED TO BE A 2 DEGREE BURN WITH BLISTERING PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC ABLATION UNIT GEI BOSTON SCIENTIFIC RF 3000 420-0555-100 REV A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| S