BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ACTICON NEOSPHINCTER

    MDR report key: 4444540 · Received January 23, 2015

    Report

    Report Number
    2183959-2015-00031
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 12, 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

    ADDITIONAL COMPONENTS: PUMP CATALOG NUMBER: 72402287, SERIAL NUMBER: (B)(4), MANUFACTURE DATE: 07/25/2006, EXPIRATION DATE: 07/20/2011. BALLOON CATALOG NUMBER: 72402106, SERIAL NUMBER: (B)(4), MANUFACTURE DATE: 06/30/2006, EXPIRATION DATE: 07/20/2011. EVALUATION SUMMARY: THE ACTICON DEVICE WAS VISUALLY INSPECTED. THERE WAS A LEAK IN THE CUFF PILLOW THAT WAS THE RESULT OF FATIGUE AND WEAR AT A FOLD. THE PUMP AND BALLOON WERE NOT FUNCTIONALLY TESTED DUE TO THE CUFF LEAK. THERE WAS A LEAK IN THE CUFF TUBE THAT WAS THE RESULT OF TOOL DAMAGE WHICH PROBABLY OCCURRED DURING REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ACTICON NEOSPHINCTER WAS REMOVED BECAUSE OF FLUID LOSS AND "RETURN TO FECAL INCONTINENCE". NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56514 AMS ACTICON NEOSPHINCTER IMPLANTED FECAL INCONTINENCE DEVICE MIP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R