BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN COACCESS ELECTRODE SYSTEM

    MDR report key: 1162740 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04598
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOS
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MFR DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVAL CANNOT BE PERFORMED; THE CAUSE OF THE MALFUNCTION IS UNDETERMINED. THE JULY 2008 15-MONTH RF PROBES PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED, NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP (BSC) IN 2008 THAT A LEVEEN COACCESS ELECTRODE SYSTEM DEVICE WAS USED DURING A RADIO FREQUENCY ABLATION PROCEDURE PERFORMED ON FOUR DAYS EARLIER. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PT PRESENTED WITH INCONTINENCE AND RECEIVED MINOR FIRST DEGREE TISSUE BURNS ON THE WAIST AND UPPER THIGH WHERE THE URINE HAD FLOWED AND TOUCHED THE GROUNDING PADS. THE BURNS WERE REPORTED TO BE VERY SMALL. FOUR PADS WERE USED DURING THE PROCEDURE, TWO ON THE UPPER PART OF EACH THIGH. THE PADS WERE MONITORED THROUGHOUT THE PROCEDURE. THE PADS WERE NOT BSC SUPPLIED PADS. THE RECOMMENDED SETTINGS WERE USED, WITH 177 WATTS BEING THE HIGHEST POWER ACHIEVED. THE PROCEDURE WAS COMPLETED WITH THIS LEVEEN COACCESS ELECTRODE SYSTEM DEVICE. ALOE LOTION WAS APPLIED TO THE BURN. THERE WAS NO SERIOUS INJURY REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN COACCESS ELECTRODE SYSTEM JOS BOSTON SCIENTIFIC CORPORATION M001262230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other