BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SINGLE-INCISION SLING

    MDR report key: 2838044 · Received November 7, 2012

    Report

    Report Number
    2183959-2012-02984
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 16, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. E1: INTERNATIONAL UROGYNECOLOGY JOURNAL OCTOBER 2012, ARTICLE TITLE: MANAGEMENT OF TWO SYNTHETIC MIDURETHRAL SLINGS ERODED INTO THE URETHRAL LUMEN. HTTP://RD.SPRINGER.COM/ARTICLE/10.1007/S00192-012-1944-3.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT# 2183959-2012-02983. RELATED TO MFR REPORT# 2183959-2012-02981. THE INTERNATIONAL UROGYNECOL JOURNAL REPORTED THAT A (B)(6) WOMAN WAS IMPLANTED WITH A MINIARC SLING, IMPLANT DATE UNK, TO TREAT HER STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PT EXPERIENCED URINARY FREQUENCY, NOCTURIA, DECREASED URINARY STREAM, STRAINING TO URINATE, AND URINARY HESITANCY SOMETIME AFTER IMPLANTATION. ADDITIONALLY, IT WAS REPORTED, SHE DEVELOPED RECURRENT STRESS URINARY INCONTINENCE AND CHRONIC PELVIC PAIN REFRACTORY TO ANALGESICS 2 MONTHS AFTER SURGERY. IT WAS ALSO REPORTED THAT THE PT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE AND THE SLING WAS INCISED. DATE OF THE PROCEDURE IS UNK. CONCURRENTLY, DURING THE MESH REVISION PROCEDURE THE PT HAD AN ADDITIONAL INCONTINENCE SLING IMPLANTED, DISTAL TO THE INITIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIARC SINGLE-INCISION SLING SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R| S