BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVANCE MALE SLING SYSTEM

    MDR report key: 1941871 · Received December 22, 2010

    Report

    Report Number
    2183959-2010-00473
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 1, 2008
    Report Date
    December 14, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A PRODUCT MALFUNCTION, PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    AN INVANCE SLING WAS IMPLANTED ON (B)(6) 2008, FOR INCONTINENCE. EXACT DATE IS NOT AVAILABLE. IN (B)(6) 2008, THE SLING WAS REMOVED DUE TO INFECTION. THE PT THEN HAD A THIRD PROCEDURE TO CLEAR OUT ADDITIONAL INFECTION, DATE OF THIRD PROCEDURE IS NOT AVAILABLE. PT REPORTS THAT HE CONTINUES TO HAVE PAIN DUE TO FAILED PROCEDURE, HAS HAD SEVERAL NERVE BLOCKS FOR PUDENDAL NERVE DAMAGE AND HAS CONTINUED INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVANCE MALE SLING SYSTEM INVANCE SLING FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S