BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE

    MDR report key: 1920296 · Received December 10, 2010

    Report

    Report Number
    3005099803-2010-05081
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K053128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE 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 THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05080 AND 3005099803-2010-05082 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND TWO SOLOIST SINGLE NEEDLE ELECTRODES WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE OF THE TIBIA PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE ELECTRODE WAS ADVANCED TO THE OSTEOID OSTEOMA. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO PROCEED WITH THE ABLATION, A GENERATOR ERROR (E03) OCCURRED. ADDITIONALLY, THE ELECTRODE BENT, BUT THE CIRCUMSTANCES SURROUNDING THE BEND ARE NOT KNOWN. A SECOND SOLOIST SINGLE NEEDLE ELECTRODE WAS THEN POSITIONED AT THE OSTEOMA, HOWEVER, THE GENERATOR ERROR (E03) RECURRED. THE PROCEDURE WAS COMPLETED USING CRYOABLATION. 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 13489158

    Patients

    Seq Age Sex Outcome Treatment
    1