BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE

    MDR report key: 1832609 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03863
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K053128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLOIST SINGLE NEEDLE ELECTRODE WAS USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) OF THE ANKLE. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING THE BONE ABLATION, A GENERATOR ERROR (E02) OCCURRED. THE PHYSICIAN REMOVED AND REPLACED THE ELECTRODE WITH ANOTHER OF THE SAME. THE SECOND ELECTRODE WAS THEN ADVANCED AND REPOSITIONED WITH RESPECT TO THE DEPTH OF THE ELECTRODE INTO THE BONE AND THE PROCEDURE WAS ABLE TO BE COMPLETED USING THIS SOLOIST SINGLE NEEDLE ELECTRODE. 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 SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262500

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR