BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 4338581 · Received December 17, 2014

    Report

    Report Number
    2183959-2014-64681
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    September 5, 2013
    Report Date
    September 17, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    OTP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 - (B)(4); AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4); AMS ELEVATE PC - (B)(4); AMS ELEVATE PC POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4); AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4); AMS INTEXEN-PORCINE DERMIS - (B)(4); AMS MINIARC SLING SYSTEM - (B)(4); AMS MONARC SLING SYSTEM - (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 EXPERIENCED RECURRENT STRESS URINARY INCONTINENCE, URINARY RETENTION, LARGE CYSTOCELE AND POOR BLADDER EMPTYING. THE MESH REMAINS IMPLANTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828261 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM MESH, SURGICAL, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS 720093-01

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention| S MONARC| MONARC