BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALYPSO BEACON TRANSPONDERS

    MDR report key: 2619273 · Received January 12, 2010

    Report

    Report Number
    2619273
    Event Type
    Injury
    Date Received
    January 12, 2010
    Date of Event
    December 30, 2009
    Report Date
    January 7, 2010
    Manufacturer
    CALYPSO MED TECHNOLOGIES INC
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT IS A (B)(6) CAUCASIAN FEMALE DIAGNOSED WITH (B)(4) NON-SMALL CELL LUNG CANCER OF THE RIGHT LUNG WHO SIGNED CONSENT ON (B)(6) 2009, TO PARTICIPATE IN THE STUDY TITLED "(B)(4)" AND REGISTERED WITH THE FDA UNDER (B)(4) 4D LOCALIZATION SYS. THE PT'S TUMOR WAS LOCATED AT THE PERIPHERY OF THE RIGHT LUNG, ALMOST PLEURAL BASED. THE PT HAD THE BEACON TRANSPONDERS AND FIDUCIAL MARKERS IMPLANTED ON THE MORNING OF (B)(6) 2009, FOR TARGETED RADIATION AS PART OF THE ABOVE-REFERENCED CLINICAL TRIAL. SHE DEVELOPED A GRADE 4 RIGHT PNEUMOTHORAX ON (B)(6) 2009, FOLLOWING THE IMPLANTATION, AND WAS SUBSEQUENTLY ADMITTED TO (B)(6). THE PNEUMOTHORAX HAD SINCE RESOLVED AND THE PT WAS DISCHARGED ON (B)(6) 2009. THE PRINCIPAL INVESTIGATOR BELIEVES THIS EVENT WAS NOT RELATED TO THE BEACON ITSELF, BUT TO THE PROCEDURE AS PNEUMOTHORAX IS A POSSIBLE COMPLICATION OF IMPLANTATION OF ANY MARKER IN THE LUNG USING FIBROTIC BRONCHOSCOPY, PARTICULARLY IN PTS WITH REALLY PERIPHERAL LUNG LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALYPSO BEACON TRANSPONDERS CALYPSO BEACON TRANSPONDERS IYE CALYPSO MED TECHNOLOGIES INC ASM0094-002 00009001

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization ASPIRIN| MULTIVITAMIN| POTASSIUM| DEPAKOTE| ALPRAZOLAM| NIASPAN| LASIX| CAPTOPRIL| DARVOCET