BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1823102 · Received September 1, 2010

    Report

    Report Number
    3005099803-2010-03585
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. (B)(4) - SURGICAL INTERVENTION TO TREAT PNEUMOTHORAX. 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 LEVEEN NEEDLE ELECTRODE WAS USED DURING A LUNG RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE FOLLOW-UP REVEALED THAT THE PATIENT HAD A PNEUMOTHORAX, WHICH THE PHYSICIAN TREATED WITH A CHEST TUBE. HOWEVER, THE DESIRED EFFECT WAS NOT ACHIEVED. THEREFORE, ON (B)(6) 2010 THE PATIENT UNDERWENT THORASCOPIC SURGERY TO TREAT THE CONDITION. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS BEING STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262280 13373795

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention