BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2581328 · Received May 17, 2012

    Report

    Report Number
    2183959-2012-00458
    Event Type
    Death
    Date Received
    May 17, 2012
    Date of Event
    March 17, 2012
    Report Date
    April 18, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: CATALOG # 72404130, SERIAL# (B)(4); CATALOG # 72400024; SERIAL # (B)(4); CATALOG # 72404127, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS ORIGINALLY IMPLANTED WITH AN ARTIFICIAL URINARY SPHINCTER TANDEM CUFF SYSTEM ON (B)(6), 2012. FOLLOWING THE IMPLANT SURGERY, THE PT EXPERIENCED POSTOPERATIVE PAIN AND EPISODES OF "FAINTING/PASSING OUT." THE SPECIFIC DATE OF THE ONSET OF SYMPTOMS WAS UNK. ON (B)(6), 2012, THE PT WAS BROUGHT TO THE EMERGENCY ROOM, ASSESSED, AND TAKEN TO SURGERY AT 1:00 AM ON (B)(4), 2012. THE DEVICE WAS EXPLANTED DUE TO "GANGRENE INFECTION IN THE URETHRA AND THE SCROTUM." URINE BEGAN LEAKING FROM THE URETHRA UPON REMOVAL OF THE CUFFS. URINE WAS ALSO NOTED TO BE LEAKING FROM THE SCROTUM. THE TESTICLES AND SCROTUM WERE REMOVED DUE TO GANGRENE. ADD'L INFO INDICATED THE PT WAS SEPTIC, EXPERIENCED A "HEART ATTACK AND PASSED AWAY". FURTHER DETAILS AND THE OFFICIAL CAUSE DEATH WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEMS, INC. AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H