BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 3318625 · Received August 26, 2013

    Report

    Report Number
    2183959-2013-00990
    Event Type
    Injury
    Date Received
    August 26, 2013
    Date of Event
    July 31, 2013
    Report Date
    July 31, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BALLOON - CATALOG #7242106, SERIAL # (B)(4), EXPIRATION DATE 10/02/2001, MANUFACTURE DATE 10/1996. PUMP - CATALOG #72402287, SERIAL # (B)(4), EXPIRATION DATE 02/28/2002, MANUFACTURE DATE 02/1997. RETURNED DEVICE ANALYSIS RESULTS INDICATE THE BALLOON RATING IS UNSATISFACTORY, AS THE BALLOON TESTED AT 90.0CMH2O AND THE BALLOON IS RATED AT 101-110CMH2O. THE CUFF RATING IS UNDETERMINED, AS THE LEAK IN THE CUFF APPEARS TO BE THE RESULT OF A SHARP INSTRUMENT WHICH PROBABLY OCCURRED DURING REMOVAL. THE PUMP RATING IS FUNCTIONAL AS THE RESISTOR FLOW RATE IS 2.00ML/MIN. THE SPECIFICATION IS 1.3-1.6ML/MIN. NO COMPLAINT OF THE CUFF REFILLING TOO FAST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HIS ACTICON NEOSPHINCTER REMOVED AND REPLACED ON (B)(6) 2013 DUE TO FLUID LOSS. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417351 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER EZY AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R