BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE

    MDR report key: 1842953 · Received September 23, 2010

    Report

    Report Number
    3005099803-2010-04021
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K053128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER IS UNKNOWN. (B)(4). 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 FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04017, 3005099803-2010-04019, AND 3005099803-2010-04020 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RF 3000 RADIOFREQUENCY GENERATORS AND TWO SOLOIST SINGLE NEEDLE ELECTRODES WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE OF THE LEG PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE FIRST GENERATOR WAS USED TO ABLATE THE LEG TUMOR FOLLOWING THE APPROPRIATE ELECTRODE ALGORITHM OF A 1 WATT POWER INCREASE PER MINUTE. THE IMPEDANCE INCREASED TOWARDS ROLL-OFF ON EACH OF THREE ABLATION ATTEMPTS WITHOUT ERROR. HOWEVER, THE PHYSICIAN REPORTED THERE WAS NO INDICATION THAT THE AREA HAD BEEN SUCCESSFULLY TREATED. THE SOLOIST ELECTRODE WAS REPOSITIONED AND THE GENERATOR WAS RESET THEN SET TO 70% OF THE MAXIMUM POWER, BUT THE PHYSICIAN WAS STILL UNCERTAIN IF THE ABLATION HAD OCCURRED. A SECOND RF 3000 RADIOFREQUENCY GENERATOR ((B)(4)) WAS OBTAINED AND USED WITH A NEW SOLOIST ELECTRODE, BUT THE SAME ISSUE RECURRED. THE IMPEDANCE INCREASED TOWARDS ROLL-OFF WITHOUT ERROR, BUT THE ABLATION DID NOT APPEAR TO OCCUR. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE ACCOUNT LATER REPORTED THAT IN A FEW INSTANCES, WHILE PERFORMING THE ABLATION, THE GENERATOR DISPLAYED AN ERROR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2010, THE PHYSICIAN REPORTED THAT THE TUMOR HAD BEEN REDUCED BY APPROXIMATELY 70%. ADDITIONALLY, THE PATIENT NO LONGER HAS LEG PAIN THAT WAS EXPERIENCED PRIOR TO HAVING THE ABLATION.

    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 12535977

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR