BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ACTICON NEOSPHINCTER

    MDR report key: 4562219 · Received March 3, 2015

    Report

    Report Number
    2183959-2015-00079
    Event Type
    Injury
    Date Received
    March 3, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 11, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    MIP
    PMA / PMN Number
    P010020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFORMATION BELOW IN ORDER OF CUFF, PUMP, BALLOON. CATALOG #: 72401978, 72402287, 72402106. EXPIRATION DATE: 07/22/2009, 03/10/2013, 03/17/2013. SERIAL #: (B)(4). DEVICE MANUFACTURE DATE: 07/26/2004, 03/12/2008, 04/01/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACTICON BOWEL SPHINCTER WAS REMOVED DUE TO RECURRING INCONTINENCE. FLUID LOSS WAS NOTED DURING EXPLANT OF THE BALLOON. ANOTHER ACTICON DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT "DID FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145758 AMS ACTICON NEOSPHINCTER IMPLANTED FECAL INCONTINENCE DEVICE MIP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R