BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 881334 · Received July 17, 2007

    Report

    Report Number
    6000037-2007-00037
    Event Type
    Injury
    Date Received
    July 17, 2007
    Date of Event
    June 13, 2007
    Report Date
    June 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. THE MAY 2007 15-MONTH RADIOFREQUENCY PROBES COMPLAINT TRENT REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. THE DIRECTIONS FOR USE FOR THIS DEVICE ON PAGE 5, UNDER INSTRUCTIONS FOR USE, RETURN PAD SELECTION AND PLACEMENT STATES, "FOLLOW MANUFACTURER'S INSTRUCTIONS FOR THE APPLICATION OF THE DISPOSABLE PATIENT RETURN ELECTRODES (RETURN PADS) AND INTERCONNECTING CABLES. BOSON SCIENTIFIC RECOMMENDS THE USE OF VALLEY LAB, INC'S "POLYHESIVE: DISPOSABLE PATIENT RETURN ELECTRODES."

    Description of Event or Problem · 1

    A LEVEEN NEEDLE ELECTRODE WAS USED FOR A THERAPEUTIC RADIOFREQUENCY ABLATION (RFA) FOR THE LIVER ON A PATIENT (AGE UNKNOWN). THE PROCEDURE WAS PERFORMED WITH OPEN SURGERY. THE ALGORITHM WAS FOLLOWED WITH THE RECOMMENDED SETTINGS USED. FIVE ABLATIONS WERE DONE WITH THE 5.0 PROBE AND WORKED ACCORDING TO THE ALGORITHM AND RF GENERATOR. THE HIGHEST POWER ACHIEVED WAS 200 WATTS. THE PROCEDURE WAS SUCCESSFULLY CONCLUDED. SUBSEQUENT TO THE PROCEDURE, UPON REMOVAL OF GROUNDING PAD AND EXAMINATION OF THE PATIENT'S THIGH, A DIME SIZED THIRD DEGREE BURN WITH BLISTERING WAS SPOTTED. THE BURN AND BLISTERING WAS TREATED WITH TOPICAL MEDICATION. IT SHOULD BE NOTED THAT CON MED PADS WERE USED IN TE PROCEDURE. ACCORDING TO THE DIRECTIONS FOR USE, CON MED IS NOT THE RECOMMENDED PAD FOR USE ALONG WITH THE LEVEEN ELECTRODE. THERE WERE NO FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE GEI BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention