BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 1924659 · Received December 10, 2010

    Report

    Report Number
    2183959-2010-00454
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 3, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG NUMBERS: 72402105 & 72402287. ADD'L LOT/SERIAL NUMBERS: (B)(4). UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BECOMES AVAILABLE REGARDING A REVISION SURGERY, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2003, A (B)(6) MALE WITH CONGENITAL ABNORMALITY AND ANAL ATRESIA WAS IMPLANTED WITH AN ACTICON DEVICE. ON (B)(6) 2010, THE ENTIRE DEVICE WAS REMOVED AND REPLACED DUE TO FLUID LOSS FROM THE CUFF.

    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 26 YR Hospitalization| R