BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 1872724 · Received October 11, 2010

    Report

    Report Number
    2183959-2010-00362
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 1, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #: 72402105, 72402287. ADDITIONAL LOT/SERIAL #: (B)(4) , (B)(4) . THE FREQUENCY OF OCCURRENCE OF THE EVENT IS ADDRESSED IN THE DEVICE LABELING. THE FREQUENCY FOR THIS EVENT IS NOT GREATER THAN IT'S USUAL. UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION. DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) FEMALE WAS IMPLANTED WITH AN ACTICON DEVICE ON (B)(6) 2005. ON (B)(6) 2010 THE ENTIRE DEVICE WAS REMOVED AND REPLACED DUE TO A "DYSFUNCTIONAL CUFF" WHICH RESULTED IN RECURRING INCONTINENCE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC. ABS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R