BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN COACCESS ELECTRODE SYSTEM

    MDR report key: 1180829 · Received September 23, 2008

    Report

    Report Number
    3005099803-2008-04784
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISCARDED. A DEVICE EVALUATION CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE JULY 2008 15-MONTH RF PROBES PRODUCT FAMILY COMPLAINT TREND CHART 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 CORPORATION IN 2008, THAT A LEVEEN COACCESS ELECTRODE SYSTEM DEVICE WAS USED DURING A RADIO FREQUENCY ABLATION PROCEDURE PERFORMED THE SAME DAY. ACCORDING TO THE COMPLAINANT, "THE PHYSICIAN TRIED TO EXPOSE THE TINES AND THEY WOULD NOT DEPLOY DUE TO THE COMPOSITION OF THE TUMOR." THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN COACCESS ELECTRODE SYSTEM GEI BOSTON SCIENTIFIC CORPORATION M001262240 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK