BEUDAMED
    FDA Adverse Event Death Summary report: N

    TARGIS SYSTEM

    MDR report key: 1257323 · Received December 5, 2008

    Report

    Report Number
    2133936-2008-00007
    Event Type
    Death
    Date Received
    December 5, 2008
    Date of Event
    November 7, 2008
    Report Date
    December 4, 2008
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISPOSABLE DEVICES WERE RETURNED, THEREFORE NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. ADDITIONALLY, THE ELECTRONIC TREATMENT FILE FROM THE CONTROL UNIT COULD NOT BE OBTAINED. A REVIEW OF UROLOGIX DEVICE HISTORY RECORDS WAS UNABLE TO BE PERFORMED SINCE NO DEVICE SPECIFIC INFORMATION WAS SHARED BY THE TREATING PHYSICIAN. UROLOGIX ATTEMPTED TO CONTACT THE PHYSICIAN ON SEVERAL OCCASIONS (VIA PHONE ON NOV 7 AND NOV 10; VIA CERTIFIED MAIL ON NOV 11) TO GATHER DEVICE AND TREATMENT INFORMATION BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAS BEEN UNCOOPERATIVE IN THE INVESTIGATION. AS NO DEVICE WAS RECEIVED FOR ANALYSIS AND NO TREATMENT FILE WAS AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT SOMETIME AFTER A TRANSURETHRAL MICROWAVE THERAPY PROCEDURE (TUMT), HIS PATIENT DEVELOPED A PERICUTANEOUS URETHRAL FISTULA, BECAME SEPTIC AND ULTIMATELY DIED. ALTHOUGH NO SPECIFIC INFORMATION WAS SHARED BY THE TREATING PHYSICIAN, IT IS BELIEVED THAT THE PATIENT WAS TREATED WITH THE TARGIS SYSTEM. UROLOGIX ATTEMPTED TO CONTACT THE PHYSICIAN ON SEVERAL OCCASIONS (VIA PHONE ON NOV 7 AND NOV 10; VIA CERTIFIED MAIL ON NOV 11) TO GATHER FURTHER INFORMATION BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAS BEEN UNCOOPERATIVE IN THE INVESTIGATION. FURTHER, UROLOGIX IS NOT ABLE TO DETERMINE IF THERE IS A RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death