BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPINCTER

    MDR report key: 2921528 · Received January 10, 2013

    Report

    Report Number
    2183959-2013-00175
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 20, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE INITIAL IMPLANT, THE RECTUM WAS PERFORATED AND THE CUFF WAS REMOVED. A DEACTIVATION KIT WAS USED AND THE PRESSURE REGULATING BALLOON AND PUMP REMAIN IMPLANTED UNTIL ANOTHER ATTEMPT CAN BE MADE TO PLACE THE CUFF. THE PT WAS IN GOOD CONDITION AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15481 ACTICON NEOSPINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention