BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 4951441 · Received July 28, 2015

    Report

    Report Number
    2183959-2014-10988
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    February 16, 2012
    Report Date
    February 11, 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

    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). LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED SEVERE ATROPHY, LEAKING, DIFFICULTY EMPTYING THE BLADDER, SOME FECAL INCONTINENCE, MIXED AND URGE INCONTINENCE, SCARRING AND BILATERAL PELVIC PAIN THAT RADIATES TO THE BACK. ADDITIONALLY, THE PLAINTIFF ALLEGEDLY EXPERIENCED EROSION, EXTRUSION, FISTULAE, RECURRENCE, BLEEDING, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, DYSPAREUNIA AND OTHER UNSPECIFIED INJURY. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS REPORTED AS MYOCARDIAL INFARCTION. RELATED TO MANUFACTURER REPORT #: 2183959-2014-31855.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490486 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM MESH, SURGICAL, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death APOGEE SYSTEM WITH PC COATED INTEPRO LITE, | ARIS TRANS-OBTURATOR.| ARIS TRANS-OBTURATOR.| APOGEE SYSTEM WITH PC COATED INTEPRO LITE,