BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVANCE MALE SLING SYSTEM

    MDR report key: 3603369 · Received January 23, 2014

    Report

    Report Number
    2183959-2013-01221
    Event Type
    Injury
    Date Received
    January 23, 2014
    Date of Event
    April 1, 2012
    Report Date
    December 29, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. (B)(4), BONE-ANCHORED SLING CREATED WITH THE INVANCE SYSTEM FOR THE TREATMENT OF INCONTINENCE AFTER RADICAL PROSTATECTOMY: INITIAL EXPERIENCE IN (B)(6). JOURNAL OF NIPPON MEDICAL SCHOOL. APRIL 2012; 79 (2): 143-146.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #2183959-2012-01222. IT WAS REPORTED VIA JOURNAL ARTICLE THE USE OF A BONE-ANCHORED SLING CREATED WITH THE INVANCE SYSTEM FOR THE TREATMENT OF URINARY INCONTINENCE AFTER RADICAL PROSTATECTOMY. THE PROCEDURE WAS PERFORMED WITH THE STRAIGHT-IN BONE-ANCHORING SYSTEM. THE PATIENT HAD USED 7 PADS/DAY FOR URINARY INCONTINENCE FOR THE 2 YEARS AFTER THE PROSTATECTOMY SURGERY. OPERATIVE TIME WAS 157 MINUTES AND BLOOD LOSS WAS 70ML. URINARY RETENTION WAS SEEN ON POSTOPERATIVE DAY 2, BUT THIS SYMPTOM RESOLVED THE NEXT DAY. POSTOPERATIVELY, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS WERE ADMINISTERED FOR PERINEAL PAIN, A COMPLICATION ASSOCIATED WITH THE BONE-ANCHORED SLING. NO URINARY INCONTINENCE WAS APPARENT AFTER REMOVAL OF THE FOLEY CATHETER, AND THE PATIENT HAS BEEN USING ONLY 1 PAD/DAY AS OF 2 YEARS AFTER SURGERY. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54189 INVANCE MALE SLING SYSTEM SURGICAL MESH, POLYMERIC OTM AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R