BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1210002 · Received October 22, 2008

    Report

    Report Number
    2133936-2008-00006
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    August 16, 2008
    Report Date
    October 17, 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 WILL BE RETURNED, THEREFORE NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. THE ELECTRONIC TREATMENT FILE 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 STANDARD PROCEDURES AND THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. THE TREATMENT FILE REVEALED AN UNEVENTFUL, ROUTINE PROCEDURE. AS NO DEVICE WAS RECEIVED FOR ANALYSIS AND THE TREATMENT FILE DEMONSTRATES AN UNEVENTFUL TREATMENT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A COOLWAVE CONTROL UNIT AND A TARGIS MICROWAVE TREATMENT CATHETER. THE PROCEDURE WAS STRAIGHTFORWARD AND UNEVENTFUL AND THE PATIENT TOLERATED THE PROCEDURE WELL. IT WAS REPORTED THAT ABOUT 5 DAYS AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, A PATIENT WENT INTO ACUTE RENAL FAILURE. THE PHYSICIAN PERFORMED CRYTOSCOPY AND CONFIRMED THAT THE PATIENT HAD EDEMA OF THE TRIGONE AT WHICH TIME HE PLACED TWO URETHRAL STENTS. LATER, THE PATIENT WENT INTO URINARY RETENTION AND HAD A TURP IN 2008. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PATIENT TO GO INTO RENAL FAILURE. THE PATIENT IS CURRENTLY DOING FINE; THE EDEMA IS RESOLVING AND HE IS VOIDING WELL. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED AND THE PATIENT IS IMPROVING. UROLOGIX IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 5000A M002972*

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other