BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGIS SYSTEM

    MDR report key: 844258 · Received April 30, 2007

    Report

    Report Number
    2133936-2007-00008
    Event Type
    Other
    Date Received
    April 30, 2007
    Date of Event
    April 11, 2007
    Report Date
    April 30, 2007
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED; THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. THE DEVICE HISTORY RECORD WAS REVIEWED. ALL MFG AND QA TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS DEVICE SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. AS NO DEVICE WAS REC'D FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 MINUTES INTO A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, A BRADYCARDIA EPISODE OCCURRED. NINE MINUTES INTO THE PROCEDURE, THE PT STARTED TO NOT RESPOND TO VERBAL STIMULI. THE PT HEART RATE DROPPED TO <25 BEATS PER MINUTE AND THE PHYSICIAN STARTED CHEST COMPRESSION. THE PROCEDURE WAS ABORTED AND THE PT WAS TRANSPORTED TO THE EMERGENCY ROOM BY EMS PERSONNEL. PT WAS DISCHARGED HOME THE NEXT DAY AND WILL HAVE F/U VISITS WITH HIS CARDIOLOGIST. IT IS NOTED THAT THE PHYSICIAN FEELS THAT THE PT HAD AN UNDERLYING CARDIAC RHYTHM ISSUE WHICH WAS EXACERBATED BY THIS PROCEDURE. NO FURTHER TREATMENTS OR SEQUELA WERE REPORTED. PT IS CURRENTLY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A 061204MC2

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other