BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 2529538 · Received April 6, 2012

    Report

    Report Number
    2133936-2012-00001
    Event Type
    Injury
    Date Received
    April 6, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISPOSABLE DEVICES WILL BE RETURNED; THEREFORE NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. THE TREATMENT FILE PRINTOUT FROM THE CONTROL UNIT WAS OBTAINED AND REVIEWED ALONG WITH THE CATHETER DEVICE HISTORY RECORD. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH THE STANDARD PROCEDURES AND THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. THE TREATMENT FILE REVEALED THAT THE SYSTEM AND CATHETER OPERATED PROPERLY AND THAT THE TREATMENT WAS INTERRUPTED BY THE OPERATOR AT THE TIME OF THE EVENT. THE PHYSICIAN SUSPECTED THAT THE PT EXPERIENCED A VASOVAGAL RESPONSE. THE PT HAS RECOVERED AND IS CURRENTLY DOING FINE.

    Description of Event or Problem · 1

    IT IS REPORTED APPROXIMATELY 2 MINUTES INTO A TRANSURETHRAL MICROWAVE TREATMENT (TUMT) PROCEDURE, THE PT¿S RECTAL TEMPERATURES BEGAN TO ELEVATE, THE PT BEGAN TO FEEL FAINT AND HIS COLOR WAS VERY PALE. THE PHYSICIAN STOPPED THE TREATMENT AND ADMINISTERED OXYGEN TO THE PT AND SUBSEQUENTLY HAD THE PT TRANSPORTED TO THE EMERGENCY ROOM. THE PT WAS NOT ADMITTED TO THE HOSPITAL, THERE WERE NO FURTHER PT INJURIES AND THE PT IS CURRENTLY DOING FINE. THE PHYSICIAN SUSPECTS THE PT HAD A VASOVAGAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM, PRODUCT CODE MEQ UROLOGIX, INC. TC1121C 120203MCA1

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other