BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS 800 URINARY CONTROL SYSTEM W/INHIBIZONE

    MDR report key: 5192141 · Received October 30, 2015

    Report

    Report Number
    2183959-2015-00457
    Event Type
    Death
    Date Received
    October 30, 2015
    Report Date
    October 2, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    EZY
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF DEATH WAS REPORTED AS "6 MONTHS AGO." CUFF: LOT/SERIAL NUMBER: (B)(4), CATALOG NUMBER: 720157-01, EXPIRATION DATE:12/20/2015. BALLOON: LOT/SERIAL NUMBER: (B)(4), CATALOG NUMBER: 72400024, EXPIRATION DATE:12/16/2019. PUMP: LOT/SERIAL NUMBER: (B)(4), CATALOG NUMBER: 72404127, EXPIRATION DATE:01/22/2016. DEVICE MANUFACTURE DATE: CUFF: 01/12/2015. BALLOON: 01/04/2015 . PUMP: 02/10/2015.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S ARTIFICIAL URINARY SPHINCTER WAS" NOT WORKING EFFECTIVELY OF DRAINING URINE AND THE PATIENT COULD NOT VOID." THE PATIENT WENT INTO "RENAL FAILURE AND PASSED AWAY." THE PHYSICIAN REPORTED THAT THE PATIENT WAS "IN BAD HEALTH."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT DIED ABOUT 2 WEEKS AFTER THE ARTIFICIAL URINARY SPHINCTER IMPLANT SURGERY, BUT THE SPECIFIC DATE WAS NOT PROVIDED. THE DEVICE WAS ACTIVATED THE DAY AFTER SURGERY, AND NOTED THAT THE DEVICE "NEVER WORKED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723452 AMS 800 URINARY CONTROL SYSTEM W/INHIBIZONE ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death