BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 4131974 · Received September 29, 2014

    Report

    Report Number
    2183959-2014-41402
    Event Type
    Death
    Date Received
    September 29, 2014
    Report Date
    July 9, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    PMA / PMN Number
    K082677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EMOTIONAL DISTRESS, SEVERE AND PERMANENT PAIN, SUFFERING, DISABILITY, IMPAIRMENT, URINARY PROBLEMS, URINARY TRACT INFECTIONS, RECURRENCE, BLEEDING, DYSPAREUNIA AND A PRODUCT PROBLEM. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORTS: 2183959-2014-41403, 41404.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604650 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM MESH, SURGICAL, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MINIARC PRECISE SLING| ELEVATE POSTERIOR