BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE

    MDR report key: 1842963 · Received September 23, 2010

    Report

    Report Number
    3005099803-2010-04018
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K053128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04022 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A SOLOIST SINGLE NEEDLE ELECTRODE WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE OF THE LEG PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE ABLATION WAS PERFORMED IN THREE CYCLES OF 15 MINUTES. PRIOR TO BEGINNING THE TREATMENT, SALINE WAS INJECTED INTO THE AREA TO BE TREATED. THE FIRST TWO CYCLES WERE PERFORMED ACCORDING TO THE SPECIFIED ELECTRODE ALGORITHM. WHILE PERFORMING THE THIRD ABLATION CYCLE, THE POWER WAS INCREASED UP TO 43 WATTS AT WHICH POINT ROLL-OFF WAS ACHIEVED. HOWEVER, AT THE CONCLUSION OF THIS CYCLE, A PUNCTURE BURN WAS IDENTIFIED. THE ACCOUNT REPORTED THAT THE DISTAL END OF THE ELECTRODE APPEARED SLIGHTLY CHARRED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND GIVEN PAIN MEDICATION. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL.

    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 10 YR Hospitalization| O