BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 4200458 · Received October 24, 2014

    Report

    Report Number
    2183959-2014-00474
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    October 17, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF HAD A MONARC SLING SYSTEM IMPLANTED TO TREAT TYPE III STRESS INCONTINENCE A NON-AMS VAGINAL SUSPENSION SYSTEM TO TREAT PROLAPSE ON THE SAME DAY. A FOLLOW-UP APPOINTMENT AT 6 WEEKS POST OPERATION WITH THE IMPLANTING SURGEON REPORTED A "GOOD SURGICAL OUTCOME." FOLLOWING THE IMPLANT THE PLAINTIFF EXPERIENCED "OCCASIONAL SUDDEN SPONTANEOUS LOSS OF URINE." ON (B)(6) 2010 AN OPERATION WAS PERFORMED TO TREAT THE "LOWER URINARY TRACT SYMPTOMS." CYSTOCOPY WAS PERFORMED AND FOUND MINIMAL URETHRAL STENOSIS, ¿SOME DEGREE OF POSTVOID RESIDUAL URINE,¿ AND DIFFUSELY INFLAMED BLADDER. ¿THE URETHRA WAS THEN DILATED TO 25 FRENCH.¿ THE PATIENT WAS PRESCRIBED LOW-DOSE ANTIMICROBIAL PROPHYLAXIS AND NITROFURANTOIN. FOLLOWING THE INTERVENTION THE PLAINTIFF EXPERIENCED OVERACTIVE BLADDER, DYSURIA, AND URGENCY. ON (B)(6) 2011 A SURGERY WAS PERFORMED TO TREAT THE MODERATE URETHRAL STENOSIS NOTED VIA URETHRAL SOUND. THE SLING WAS INCISED AND URETHRAL SOUND "PASSED EASIER INTO THE BLADDER AT THIS POINT.¿ A FOLLOW-UP APPOINTMENT 4 WEEKS POST OPERATION FOUND COMPLETE RESOLUTION OF ¿DRIBBLINGS¿ AND URINARY TRACT INFECTIONS. SOME URGENCY AND FREQUENCY ¿WHICH SHE HAD PREVIOUS TO HER SURGERY.¿ IN (B)(6) 2012 THE PLAINTIFF REPORTED "SIGNIFICANT URINARY TRACT INFECTIONS¿ THAT IMPROVED FOLLOWING THE AFOREMENTIONED SURGERIES, HOWEVER, "THEY HAVE OFTEN BEEN ASSOCIATED WITH SEXUAL ACTIVITY AND MAY POSSIBLY BE ASSOCIATED WITH GENITAL PROLAPSE. PELVIC EXAM DEMONSTRATED A NORMAL INTROITUS, MODERATE CYSTOCELE, NO RECTOCELE, GOOD KEGEL RESPONSE, ADEQUATE VAULT SUPPORT AND NO MASSES COULD BE FELT.¿ THE PLAINTIFF ALSO EXPERIENCED ISSUES WITH VAGINAL DISCHARGE THAT ARE "CULTURE NEGATIVE." THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678973 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM