BEUDAMED
    FDA Adverse Event Injury Summary report: N

    700 LGX, MS PUMP

    MDR report key: 3888994 · Received June 17, 2014

    Report

    Report Number
    MW5036729
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    December 15, 2013
    Report Date
    June 16, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011 I RECEIVED A PENILE PROSTHESIS IMPLANT PROVIDED BY AMERICAN MEDICAL SYSTEMS. IT CONSISTED OF A 700LGX, MS PUMP, AMS 700 RESERVOIR, LEFT CYLINDER BODY, RIGHT CYLINDER BODY, AMS 700 ACCESSORY KIT. THIS WAS IMPLANTED BY (B)(6). IT WORKED WELL AT FIRST, BUT AFTER A FEW MONTHS THE PUMP GOT PROGRESSIVELY HARDER TO OPERATE AND IT FINALLY FAILED COMPLETELY IN (B)(6), 2013. (B)(6) CONFIRMED THE DEVICE HAD COMPLETELY MALFUNCTIONED ON (B)(6), 2014. IT NEEDS TO BE REPLACED AS SOON AS POSSIBLE, BUT, AMERICAN MEDICAL SYSTEMS HAS FAILED TO RESPOND TO ANY OF MY REQUESTS FOR PROVIDING REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356174 700 LGX, MS PUMP MS PUMP FHW AMERICAN MEDICAL SYSTEMS 700 LGX 690014001

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability