BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGIS SYSTEM

    MDR report key: 829082 · Received November 8, 2006

    Report

    Report Number
    2133936-2006-00013
    Event Type
    Other
    Date Received
    November 8, 2006
    Date of Event
    September 15, 2004
    Report Date
    November 8, 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 RECEIVED 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 PT THROUGH THE MEDWATCH SYSTEM THAT THE TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE DID NOT REDUCE HIS PROSTATE SIZE. IN ADDITION, WEEKS AFTER THE PROCEDURE, THE PT EXPERIENCED EXCRUCIATING PAIN, EFFUSIVE BLEEDING AND LIFE THREATENING INFECTION. THE TREATING PHYSICIAN WAS AWARE OF THESE SYMPTOMS AND WAS NOT CONCERNED. ALSO, AFTER THE PROCEDURE, THE PT WAS DIAGNOSED WITH CANCER IN HIS ABDOMEN, WHICH WAS REMOVED SURGICALLY. UPON FOLLOW UP, IT WAS REPORTED BY THE PHYSICIAN'S ATTORNEY THAT THE PT HAVE PREEXISTING HISTORY OF CHRONIC URINARY TRACT INFECTION (UTI) REQUIRING MEDICAL ATTENTION, FOLEY DEPENDENT, PNEUMONIA, ERECTILE DYSFUNCTION (ED), COMPLETE RETENTION, PSA >20, HYDROCELE REPAIR, AND HYPERTENSION. IN ADDITION, THE PATIENT'S IS CLAIMING THAT HIS CANCER WAS CAUSED FROM THE TRANSURETHRAL MICROWAVE TREATMENT . THE PT IS CURRENTLY IN STABLE CONDITION 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 72 YR Other