BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 3910022 · Received June 11, 2014

    Report

    Report Number
    2183959-2014-15217
    Event Type
    Death
    Date Received
    June 11, 2014
    Report Date
    July 17, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K011251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EMOTIONAL DISTRESS AND PRODUCT PROBLEM. ADDITIONALLY, THE PLAINTIFF ALLEGEDLY EXPERIENCED FISTULA, ABSCESS AND UNDERWENT SUBSEQUENT MULTIPLE REVISION, MULTIPLE ABDOMINAL PELVIC SURGERIES AND CORRECTIVE PROCEDURES. IT WAS ALSO REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346132 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death IMPLANTED:| TVT-OBTURATOR