BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE

    MDR report key: 2892050 · Received December 26, 2012

    Report

    Report Number
    2892050
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 26, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED PAINFUL VAGINAL MESH EROSION AFTER CYSTOCELE REPAIR WITH ELEVATE MESH IN 2010.SHE DOES NOT HAVE ANY SYMPTOMATIC PROLAPSE AT THE PRESENT TIME, BUT DOES HAVE PAIN THAT SEEMS TO BE RELATED TO THE MESH PLACEMENT. PALPATING THE UPPER PORTION OF THE ANTERIOR MESH UP WHERE THE ARM COMES OFF OF THE BODY CONSISTENTLY REPRODUCED HER DISCOMFORT. THERE WERE SEVERAL SMALL 0.5 CENTIMETER AREAS WHERE FIBERS WERE EXPOSED NEAR THE TOP OF THE VAGINA.OPERATIVE FINDINGS: THERE WERE TWO LINEAR AREAS OF MESH EXPOSURE AT THE CERVICOVAGINAL JUNCTION. IN THE UPPER PART OF THE VAGINA ADJACENT TO THAT IN THE MIDLINE, THERE WAS A THIN AREA OF VAGINAL EPITHELIUM THAT WAS THERE FROM THE PREVIOUS MESH EXCISION. THE MESH WAS INTACT FROM SIDE-TO-SIDE BELOW THAT IN THE AREA OF THE URINARY TRIGONE.THERE DID NOT SEEM TO BE PARTICULAR INFLAMMATION AND THERE WAS NOT OVER FOLDING. THERE WAS EXTRUSION AS PREVIOUSLY MENTIONED. THE ARMS EXTENDED UP INTO A PROPER LOCATION UP TOWARDS THE SACROSPINOUS LIGAMENT. WE WERE ABLE TO IDENTIFY THE ELEVATE DISK ON THE PATIENT'S RIGHT-HAND SIDE, BUT ON THE LEFT HAND SIDE IT WAS ABOVE THE AREA THAT WAS DISSECTIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE MESH, SURGICAL, GYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRAN OTP AMERICAN MEDICAL SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR