BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1832625 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03905
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A RENAL RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO ABLATE THE KIDNEY, A GENERATOR ERROR OCCURRED. THE CONNECTIONS WERE CHECKED AND THE SYSTEM RESTARTED, BUT THE ERROR RECURRED. THE ELECTRODE WAS THEN REPLACED WITH ANOTHER OF THE SAME AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'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 ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262230 13418415

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR