BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 1760404 · Received July 12, 2010

    Report

    Report Number
    2183959-2010-00303
    Event Type
    Injury
    Date Received
    July 12, 2010
    Date of Event
    May 5, 2010
    Report Date
    July 7, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #: 72402105, 72402287. (B)(4). UNABLE TO OBTAIN REASON FOR THIS EVENT AND THE DEVICE. THEREFORE, UNABLE TO INDICATE THE FREQUENCY OF OCCURRENCE FOR THIS EVENT OR INDICATE IF THE EVENT IS GREATER THAN USUAL OR IF IT IS ADDRESSED IN OUR LABELING. WE HAVE REQUESTED ADDITIONAL INFORMATION FROM THE DOCTOR AND CURRENTLY WAITING ON HIS RESPONSE. AS SOON AS AMS RECEIVES ADDITIONAL INFORMATION, WE WILL FILE A FOLLOW-UP REPORT. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) FEMALE, WITH NEUROLOGICAL DISORDER WAS IMPLANTED WITH AN ACTICON DEVICE ON (B)(6)2005. ON (B)(6)2010, THE ENTIRE DEVICE WAS REMOVED AND REPLACED REASON NOT INDICATED. AMS HAS REQUESTED ADDITIONAL INFORMATION TO OBTAIN A REASON PROMPTING THIS SURGERY AND THE PATIENT'S OUTCOME.

    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 60 YR Hospitalization| R