BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 2132783 · Received June 17, 2011

    Report

    Report Number
    3005099803-2011-02112
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS REPORTED AS NOT BEING EXPIRED. 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 TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02111 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN NEEDLE ELECTRODE WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A GENERATOR ERROR (E02) OCCURRED. THE ERROR WAS ABLE TO BE CLEARED BY RESETTING THE GENERATOR AFTER PLUGGING THE ELECTRODE INTO THE GENERATOR AND ADVANCING THE DEVICE INTO THE PATIENT. THE USER FURTHER REPORTED THAT WHILE PERFORMING THE ABLATION THE GENERATOR HAD TO BE CONTINUOUSLY RESET TO ADJUST POWER SETTINGS. HOWEVER, THE PROCEDURE WAS ABLE TO COMPLETED WITH THE SAME RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN NEEDLE ELECTRODE. NO ISSUES WITH VISIBLE WITH THE GENERATOR OR ELECTRODE. ADDITIONALLY, ON (B)(6), 2011, THE SALES REPRESENTATIVE WAS ON-SITE TO PERFORM A PRODUCT DEMO AND FOUND NO ISSUES WITH THE RF 3000 RADIOFREQUENCY GENERATOR. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262040

    Patients

    Seq Age Sex Outcome Treatment
    1