BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 3820561 · Received May 20, 2014

    Report

    Report Number
    2183959-2014-00165
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 14, 2013
    Report Date
    June 5, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH AN ELEVATE PC ANTERIOR AND APICAL PROLAPSE REPAIR SYSTEM ON (B)(6) 2013. AS OF (B)(6) 2013, THE PATIENT EXPERIENCED PAIN DURING PHYSICAL EXERCISE, PALPATION, AND DYSPAREUNIA. THE PATIENT BEGAN PHYSIOTHERAPY TRIGGER POINT TREATMENT ON (B)(6) 2013 AND BEGAN MONTHLY ONGOING PHYSIOTHERAPY INCLUDING TRIGGER POINT TREATMENT AND LOCAL "NERVAL THERAPY" TRANSVAGINALLY AND TRANSABDOMINALLY ON (B)(6) 2014. THE EVENT WAS NOT RESOLVED AS OF (B)(6) 2014. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298903 AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S