BEUDAMED
    FDA Adverse Event Death Summary report: N

    TARGIS SYSTEM

    MDR report key: 2342592 · Received November 18, 2011

    Report

    Report Number
    2133936-2011-00016
    Event Type
    Death
    Date Received
    November 18, 2011
    Date of Event
    October 25, 2011
    Report Date
    November 15, 2011
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICES WERE NOT RETURNED; THEREFORE NO DIRECT DEVICE ANALYSIS WAS CONDUCTED. THE TREATMENT FILE FROM THE COOLWAVE CONTROL UNIT WAS OBTAINED AND ANALYZED BY ENGINEERING. RESULTS OF THE ANALYSIS CONFIRM THAT THE CONTROL UNIT OPERATED PROPERLY. THE CATHETER AND RTU DEVICE HISTORY RECORDS WERE REVIEWED; ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES, AND THE DEVICES MET SPECIFICATIONS AT THE TIME OF RELEASE. AS THE PATIENT HAD A HISTORY OF HEART ISSUES INCLUDING 4 STENTS, IT IS REASONABLE TO CONCLUDE THAT THIS WAS A CONTRIBUTING FACTOR TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED A HEART ATTACK DURING A TRANSURETHRAL MICROWAVE TREATMENT (TUMT) AND LATER DIED AT THE HOSPITAL. AT APPROXIMATELY 14 MINUTES INTO TREATMENT, THE PATIENT BEGAN COMPLAINING OF CHEST PAINS AND STARTED HITTING HIS CHEST WITH HIS LEFT HAND. WHEN ASKED IF HE WAS OKAY, THE PATIENT REPLIED THAT HE COULD NOT BREATHE WHILE CONTINUING TO POUND ON HIS CHEST WITH THE FINGERS ON HIS LEFT HAND. THE PATIENT WAS ALSO ABLE TO SIGNIFY THAT HE HAD A HISTORY OF HEART ISSUES WHEN ASKED AND IT WAS LATER CONFIRMED THAT THE PATIENT HAD FOUR CARDIAC STENTS PLACED PRIOR TO THE TUMT. THE TREATMENT WAS ABORTED AND 911 WAS CALLED; HOWEVER, THE PATIENT BECAME NON-RESPONSIVE. THE UROLOGIX APPLICATION SPECIALIST AND PHYSICIAN MONITORED THE PATIENT'S VITAL SIGNS AND BEGAN CHEST COMPRESSIONS WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. THE PARAMEDICS WERE ABLE TO REVIVE THE PATIENT WHEN TRANSPORTING HIM TO THE HOSPITAL; HOWEVER, THE PATIENT SUFFERED A SECOND MYOCARDIAL INFARCTION AT THE HOSPITAL AND DIED A SHORT TIME LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 5000A 110920MCA1

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death