BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 4852492 · Received June 18, 2015

    Report

    Report Number
    2183959-2015-00254
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    June 12, 2015
    Report Date
    May 29, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ELEVATE ANTERIOR IMPLANTED IN (B)(6) 2014. THE PATIENT EXPERIENCED PAIN WITH PALPATION AT BOTH ISCHIAL SPINES. THE PAIN BECAME SEVERE 8-9 WEEKS PRIOR TO THE REVISION SURGERY ON (B)(6) 2015. DURING THE REVISION SURGERY, AN INCISION WAS MADE AND THE PATIENT'S RIGHT LOCKING EYELET WAS CUT OFF THE END OF THE MESH ARM AND REMOVED. ON THE PATIENT'S LEFT THE ENTIRE ARM DISTAL TO THE FIXATION TIP WAS REMOVED INCLUDING THE LOCKING EYELET. AFTER THIS WAS COMPLETED A RECTAL EXAM DISCOVERED A RECTAL PERFORATION. THIS WAS CLOSED UNDER DIRECT VISION IN MULTIPLE LAYERS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396690 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R