BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 4090657 · Received September 15, 2014

    Report

    Report Number
    2183959-2014-00405
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 1, 2013
    Report Date
    August 20, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RELATED TO MANUFACTURER REPORT # 2183959-2014-00404, 2183959-2014-00406, 2183959-2014-00407.IT WAS REPORTED THE PATIENT EXPERIENCED GENUINE STRESS INCONTINENCE LEAKING URINE WHILE COUGHING AND WALKING FOLLOWING THE IMPLANTATION OF AN ELEVATE PC ANTERIOR GRAFT. ANOTHER MANUFACTURER'S SLING WAS IMPLANTED ON (B)(6) 2013 WHICH RESOLVED THE EVENT.. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569990 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ELEVATE PC POSTERIOR