BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGIS SYSTEM

    MDR report key: 771252 · Received October 6, 2006

    Report

    Report Number
    2133936-2006-00012
    Event Type
    Other
    Date Received
    October 6, 2006
    Date of Event
    April 1, 2005
    Report Date
    October 6, 2006
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE HAS BEEN RETURNED, THEREFORE NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. 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 BY THE PATIENT THROUGH THE MEDWATCH SYSTEM THAT DURING A TRANSURETHRAL MICROWAVE, TREATMENT PROCEDURE, THE PT EXPERIENCED SIGNIFICANT PAIN DURING AND AFTER THE TREATMENT. IN ADDITION, THE PATIENT REPORTED THAT AFTER THE PROCEDURE, HE EXPERIENCED INCONTINENCE, ERECTILE DYSFUNCTION, AND MAJOR BLEEDING. UPON FURTHER FOLLOW UP THE PT HAS PREEXISTING HISTORY OF ERECTILE DYSFUNCTION , INCONTINENCE, GROSS HEMATURIA, ELEVATED PSA, ACUTE AND CHRONIC PROSTATITIS. IN ADDITION, THE PHYSICIAN'S NOTES STATES THE PT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED. PATIENT IS CURRENTLY IN STABLE CONDITION AND AT HOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other