BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1674256 · Received April 29, 2010

    Report

    Report Number
    2133936-2010-00009
    Event Type
    Injury
    Date Received
    April 29, 2010
    Date of Event
    March 28, 2009
    Report Date
    April 29, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICES WERE NOT RETURNED; THEREFORE, NO DIRECT DEVICE ANALYSIS WAS CONDUCTED. THE TREATMENT FILE PRINTOUT WAS OBTAINED AND THE CONTROL UNIT OPERATED PROPERLY. THE CATHETER AND RTU DEVICE HISTORY RECORDS WERE REVIEWED; ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES AND THE DEVICES MET SPECIFICATIONS AT THE TIME OF RELEASE. AS NO DEVICE WAS RETURNED FOR ANALYSIS AND THE TREATMENT FILE DEMONSTRATES THE CONTROL UNIT OPERATED APPROPRIATELY, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. IT IS NOTED THAT LOSS OF EJACULATE HAS BEEN OBSERVED DURING CLINICAL STUDIES WITH AN EVENT RATE BETWEEN 2-10% AS LISTED IN CURRENT (B) (4) LABELING. THE LABELING ALSO INDICATES THAT PHYSICIANS SHOULD INFORM PTS THAT LOSS OF EJACULATE MAY OCCUR AS A RESULT OF CTT AND THUS SHOULD BE CONSIDERED BY MEN WHO MAY WISH TO HAVE FURTHER OFFSPRING.

    Description of Event or Problem · 1

    THE PT REPORTED LOSS OF EJACULATE SEVERAL MONTHS AFTER A TRANSURETHRAL MICROWAVE TREATMENT (TUMT) PROCEDURE. THE PHYSICIAN SUCCESSFULLY COMPLETED THE TUMT PROCEDURE WITH A UROLOGIX COOLWAVE CONTROL UNIT AND CTC ADVANCE (3.0-5.0 CM) MICROWAVE TREATMENT CATHETER. NO FURTHER INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 5000A 080911MCA1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other HAD LASER PVP