BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 826253 · Received March 8, 2007

    Report

    Report Number
    6000037-2007-00009
    Event Type
    Death
    Date Received
    March 8, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 16, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    JOS
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE IF THE DEVICE MET SPEC. A REVIEW OF OUR COMPLAINT DATA FOR THE LAST FIFTEEN MOS SHOW THAT THERE WERE NO OTHER RELATED DEATH COMPLAINTS ASSOCIATED WITH THIS PRODUCT CODE AND FAILURE MODE. OUR MONTHLY TREND REPORT FOR THE PAST 15 MOS ALSO SHOWS NO UNFAVORABLE TRENDS FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 16 FEBRUARY 2007, THAT A PT EXPIRED FOUR DAYS AFTER UNDERGOING RADIOFREQUENCY ABLATION THERAPY FOR RENAL CELL CARCINOMA. THE RADIOFREQUENCY ABLATION PROCEDURE WAS SUCCESSFUL, HOWEVER, THE PT DID SUFFER BLOOD LOSS RELATED TO ANTICOAGULATION THERAPY; THE PT WAS ON COUMADIN. AFTER F/U WITH THE SALES REP AND PHYSICIAN IT WAS NOTED THAT THE PT SUFFERED A MYOCARDIAL INFARCTION THAT WAS UNRELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURG, ELECTRODE JOS BOSTON SCIENTIFIC CORP. 26-223 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death