BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1915203 · Received November 2, 2010

    Report

    Report Number
    2024601-2010-00858
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE IMPLANT. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PORT WHICH THE REPORTER INDICATED HAD THE ISSUE. ANALYSIS AND TESTING HAS BEEN DONE ON THE BAND PORTION AND INDICATED IT WAS INTACT AND FUNCTIONAL. FURTHER INFO FROM THE REPORTER REGARDING THE IMPLANT DATE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    THE DEVICE ANALYSIS LAB RECEIVED A DEVICE WITH A REPORTING OF "FAILED PORT - LEAK UPON FLUSHING." ONLY THE BAND PORTION OF THE DEVICE WAS RECEIVED. FURTHER F/U WILL BE CONDUCTED TO GATHER ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1768836

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR