BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 1942366 · Received December 22, 2010

    Report

    Report Number
    2183959-2010-00471
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 30, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO SUBSTANTIATE IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. THE EVENT IS CAPTURED IN OUR LABELING AS A FORESEEABLE EVENT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH ANORECTAL AND OBSTETRIC TRAUMA WAS IMPLANTED WITH AN ACTION DEVICE ON (B)(6) 2002. ON (B)(6) 2010, THE PUMP WAS REMOVED AND REPLACED DUE TO PT DISSATISFACTION CAUSED BY "PUMP MALFUNCTION".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R