BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS ARTIFICIAL URINARY SPHINCTER ACCESSORY KIT

    MDR report key: 5010031 · Received August 18, 2015

    Report

    Report Number
    5010031
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    June 10, 2015
    Report Date
    August 4, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS INC
    Product Code
    FAG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TAKEN TO SURGERY FOR REPLACEMENT OF A MALFUNCTIONING ARTIFICIAL URINARY SPHINCTER. THE DEVICE WAS NO LONGER WORKING AND PATIENT DESIRED TO HAVE IT REPLACED. THIS DEVICE WAS PLACED APPROXIMATELY 8 YEARS AGO STATUS POST RADICAL RETROPUBIC PROSTATECTOMY AND STRESS INCONTINENCE. FOUR COMPONENTS HAD BEEN IMPLANTED AT THAT TIME: AMS 800 (TM) IZ ACCESSORY KIT REF (B)(4), LOT # 515617014; AMS PRESS REG BALLOON REF (B)(4), LOT # 512424002 61-70 CM H20; AMS 800 CONTROL PUMP WITH IZ REF (B)(4), LOT # 508541007; AMS S.T. CUFF WITH IZ REF (B)(4), LOT # 502270006 4 CM. PATIENT'S POST-OP COURSE AFTER REPLACEMENT WAS ROUTINE WITH NO COMPLICATIONS. PATIENT WAS DISCHARGED HOME THE DAY AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543923 AMS ARTIFICIAL URINARY SPHINCTER ACCESSORY KIT DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC FAG AMERICAN MEDICAL SYSTEMS INC 800 515617014

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other