BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 5052926 · Received September 3, 2015

    Report

    Report Number
    2183959-2014-38217
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    November 21, 2014
    Report Date
    January 28, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    PMA / PMN Number
    K082677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED (B)(6) 2014 UNDER EXEMPTION (B)(4). ADDITIONALLY, THIS WAS REPORTED ON THE SUMMARY REPORT DATED (B)(6) 2015 UNDER EXEMPTION (B)(4). ADDITIONALLY, THIS WAS REPORTED ON THE SUMMARY REPORT DATED (B)(6) 2015 UNDER EXEMPTION (B)(4). LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, EROSION, URINARY PROBLEMS, BOWEL PROBLEMS, NEUROMUSCULAR PROBLEMS, EMOTIONAL DISTRESS, EXTRUSION AND OTHER UNSPECIFIED INJURIES. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED RECURRENT STRESS URINARY INCONTINENCE, OVERACTIVE BLADDER, CYSTOCELE, ENTEROCELE, PERIURETHRAL SCARRING, VESICOVAGINAL SPACE SCARRING, VAGINAL CUFF PROLAPSE, AND RECTOCELE. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH REPORTED WAS COLORECTAL CANCER WITH METASTASIS. RELATED TO MANUFACTURER REPORT #S: 2183959-2014-38214, 2183959-2014-38223, AND 2183959-2015-12891.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586555 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM MESH, SURGICAL, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death MONARC| PERIGEE| UNKNOWN SLING| UNKNOWN SLING