BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SINGLE-INCISION SLING

    MDR report key: 2838053 · Received November 7, 2012

    Report

    Report Number
    2183959-2012-02983
    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. 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# 2183959-2012-02981. RELATED TO MFR REPORT# 2183959-2012-02984. THE INT. UROGYNECOL JOURNAL REPORTED THAT A (B)(6) WOMAN WAS IMPLANTED WITH A SECOND MINIARC SLING TO TREAT RECURRENT STRESS URINARY INCONTINENCE (SUI); THE DATE OF IMPLANT WAS NOT PROVIDED. IT IS REPORTED, THE PT CONTINUED TO EXPERIENCE SUI AND PAIN AFTER THE SECOND IMPLANT PROCEDURE. ANOTHER UROLOGIST RECOMMENDED BIOFEEDBACK AND PROVIDED A REFERRAL. IT WAS REPORTED THAT THE PT HAD RECURRENT URINARY TRACT SYMPTOMS, INCLUDING URINARY FREQUENCY, NOCTURIA, DECREASED URINARY STREAM, STRAINING TO URINATE, AND URINARY HESITANCY. A PHYSICAL EXAM COULD NOT BE DONE DUE TO "EXQUISITE VAGINAL PAIN." A URETHROCYSTOSCOPY REVEALED TWO MIDURETHRAL SLING EROSIONS. ONE WAS PROXIMAL, MEASURING 1 CM X 3-4 CM. THE SECOND WAS MORE DISTAL, MEASURING 1 CM X 2 CM. THE PT WAS PLACED ON PROPHYLACTIC ANTIBIOTICS AND THE MESH WAS SUCCESSFULLY REMOVED FROM THE URETHRA UTILIZING A HOLMIUM LASER. SIX WEEKS FOLLOWING THE LASER PROCEDURE, A CYSTOSCOPY REVEALED NO MESH SEGMENTS IN THE URETHRAL LUMEN. HOWEVER, THE PT STILL HAD SIGNIFICANT PAIN AND DYSPAREUNIA AND A SECOND PROCEDURE WAS PERFORMED REMOVING THE REMAINING MESH SEGMENTS OUTSIDE THE URETHRAL WALL.

    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 PRIOR MINIARC SLING IMPLANTED