BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 5091515 · Received September 21, 2015

    Report

    Report Number
    2183959-2014-63075
    Event Type
    Death
    Date Received
    September 21, 2015
    Report Date
    September 8, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K011251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED AN UNSPECIFIED INJURY AND A PRODUCT PROBLEM. THE DEVICE REMAINS IMPLANTED. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #: 2183959-2014-63118, RELATED TO MANUFACTURER REPORT #: 2183959-2014-63794, RELATED TO MANUFACTURER REPORT #: 2183959-2014-63767, AND RELATED TO MANUFACTURER REPORT #: 2183959-2014-63766.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621633 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ELEVATE ANTERIOR| MINIARC SLING| MONARC+ SUBFASCIAL HAMMOCK| PERIGEE| PERIGEE