BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 4047162 · Received August 29, 2014

    Report

    Report Number
    2183959-2014-10170
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    July 19, 2010
    Report Date
    August 29, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TOTAL NUMBER OF EVENTS SUMMARIZED - (B)(4). AMS APOGEE PC WITH INTEXEN LP - (B)(4). AMS APOGEE SYSTEM - (B)(4). AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE - (B)(4). AMS ELEVATE (NOT SPECIFIED) - (B)(4). AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS ELEVATE PC - (B)(4). AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS INTEPRO Y-MESH - (B)(4). AMS MINIARC SLING SYSTEM - (B)(4). AMS MONARC SLING SYSTEM - (B)(4). AMS MONARC + SUBFASCIAL HAMMOCK - (B)(4). AMS PERIGEE SYSTEM - (B)(4). AMS PERIGEE SYSTEM WITH INTEPRO - (B)(4). AMS PERIGEE SYSTEM WITH PC COATED INTEPRO LITE - (B)(4). AMS SPARC SLING SYSTEM - (B)(4). UNKNOWN GRAFT MESH - (B)(4). UNKNOWN SLING SYSTEM - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, VAGINAL BLEEDING, RECTAL AND VAGINAL DISCHARGE, ATROPHIC VAGINITIS AND FELT A LOT OF PELVIC PRESSURE, PERSISTENT URINARY TRACT INFECTION, DYSURIA, NON HEALING TISSUE, DRAINAGE AND ODOR IN THE VAGINA AND CONTINUED INCONTINENCE. THE DEVICE REMAINS IMPLANTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528413 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM MESH, SURGICAL, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention GYNECARE TVT| GYNECARE TVT