BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 957551 · Received November 1, 2007

    Report

    Report Number
    3004962788-2007-00026
    Event Type
    Injury
    Date Received
    November 1, 2007
    Date of Event
    October 3, 2007
    Report Date
    October 31, 2007
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 10/4/07, SUPERDIMENSION WAS INFORMED BY DR. THAT IN 2007, HE HAD A PT CASE FOR FIDUCIAL MARKER PLACEMENT FOR THE CYBERKNIFE PROGRAM. THE LESION WAS IN THE UPPER LOBE AND HE WAS ASKED BY THE CYBERKNIFE GROUP TO PLACE 4-6 GOLD CYLINDERS. THE PHYSICIAN PLACED ONE 5MM AND FOUR 3MM MARKERS. A CHEST X-RAY WAS TAKEN THAT NIGHT AND IT WAS DISCOVERED THAT THE PT HAD A PNEUMOTHORAX. NO FURTHER PT INFO COULD BE OBTAINED. THE HOSP DID NOT KEEP A RECORD OF THE LOT OR SERIAL NUMBER OF THE DEVICE USED. DR. DID NOT BELIEVE THE PNEUMOTHORAX WAS IN ANY WAY RELATED TO THE SUPERDIMENSION DEVICE. THEREFORE, HE DID NOT WANT TO GIVE ANY FURTHER PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY, X-RAY SYSTEM JAK SUPERDIMENSION, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization