BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 1932995 · Received December 10, 2010

    Report

    Report Number
    2183959-2010-00448
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    March 15, 2010
    Report Date
    December 9, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    SAME PATIENT AS 2183959-2010-00449. PATIENT HAD AN AMS ACTICON NEOSPHINCTER DEVICE IMPLANTED 10 YEARS AGO (DATE UNKNOWN). ON (B)(6) 2010, THERE WAS A REVISION SURGERY FOR THE PUMP AND BALLOON ASSOCIATED WITH THE DEVICE DUE TO FLUID LOSS. THE CUFF REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC. ABS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R