BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 1894868 · Received November 10, 2010

    Report

    Report Number
    3005099803-2010-04603
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT STATED THAT THE DEVICE WILL NOT BE RETURNED; THEREFORE, ANALYSIS OF THE DEVICE CANNOT BE COMPLETED, AND THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. THE PHYSICIAN WAS PERFORMING A BONE ABLATION. THE DIRECTIONS FOR USE (DFU) DOCUMENT INDICATES THAT THE RF 3000 RADIOFREQUENCY AND LEVEEN ELECTRODE ARE INTENDED TO BE USED FOR THERMAL COAGULATION NECROSIS OF SOFT TISSUES, INCLUDING PARTIAL OR COMPLETE ABLATION OF NONRESECTABLE LIVER LESIONS. THE DEVICE IS NOT SPECIFICALLY INDICATED FOR RADIOFREQUENCY ABLATION OF THE BONE. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04602 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN ELECTRODE WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A GENERATOR ERROR (E03) OCCURRED. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER UNK373

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR