BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 1842848 · Received September 16, 2010

    Report

    Report Number
    2183959-2010-00343
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 9, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: CUFF HAD A FATIGUE LEAK. PUMP WAS FUNCTIONAL. TUBING HAD OPERATING ROOM DAMAGE. THE FREQUENCY OF OCCURRENCE OF THE EVENT IS ADDRESSED IN THE DEVICE LABELING. THE FREQUENCY FOR THIS EVENT IS NOT GREATER THAN IS USUAL. THE ANALYSIS RESULTS INDICATE THE CUFF DEVICE WAS OUT OF SPECIFICATION, FAILURE WAS RELATED TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH NEUROLOGIC DISORDER WAS IMPLANTED WITH AN ACTION DEVICE ON (B)(6) 2002. ON (B)(6) 2010, THE 13.0CM CUFF AND PUMP WERE REMOVED AND REPLACED USING A 10.0 CUFF, BALLOON AND PUMP DUE TO FECAL INCONTINENCE, ATROPHY AND DEVICE NOT WORKING PROPERLY. IT APPEARS THE OLD BALLOON WAS LEFT IN PLACE AND DEACTIVATED WAS NOT RETURNED WITH THE EXPLANTED CUFF AND PUMP.

    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 53 YR Hospitalization| R