BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1830400 · Received September 10, 2010

    Report

    Report Number
    3005099803-2010-03862
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-03859, 3005099803-2010-03860, AND 3005099803-2010-03861 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR, A LEVEEN COACCESS ELECTRODE SYSTEM AND TWO SOLOIST SINGLE NEEDLE ELECTRODES WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER PLACING THE PATIENT UNDER GENERAL ANESTHESIA, A SOLOIST ELECTRODE WAS ADVANCED TO THE TARGET REGION. HOWEVER, WHILE ATTEMPTING TO ABLATE, A CONSOLE ERROR (E02) OCCURRED. THE ELECTRODE WAS REMOVED FROM THE PATIENT AND A SECOND SOLOIST ELECTRODE WAS ADVANCED TO THE TARGET AREA, HOWEVER, A SECOND ERROR (E02) OCCURRED. THE ELECTRODE WAS REPOSITIONED DEEPER INTO THE BONE AND SALINE WAS APPLIED TO THE SITE, BUT THE ERROR REOCCURRED. THE SECOND SOLOIST ELECTRODE WAS REMOVED FROM THE PATIENT AND A LEVEEN COACCESS ELECTRODE WAS POSITIONED AND PARTIALLY DEPLOYED INTO THE LESION. THE PHYSICIAN HAD SOME SUCCESS, BUT ROLL-OFF WAS NOT ABLE TO BE ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262220

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR