BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2240816 · Received August 16, 2011

    Report

    Report Number
    2024601-2011-00633
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    March 28, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. 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

    HEALTH PROFESSIONAL REPORTED AN ALLEGED LEAK WITH A LAP-BAND PORT. A "A PORT REPLACEMENT" WAS PERFORMED AS THE SURGEON BELIEVED THERE MAY HAVE BEEN A "SLOW LEAK." FOLLOW-UP FINDINGS: THE "PATIENT" WAS "NOT GETTING ANY RESTRICTION FOR LONG PERIODS OF TIME. FLUID WAS ADDED" TO THE BAND AND "RECHECKED" A "MONTH LATER." MISSING FLUID WAS NOTICED MULTIPLE TIMES. THE SURGEON WAS "UNSURE WHERE "THE LEAK WAS LOCATED" AS THE SURGEON WAS "UNABLE TO FIND IT" AT THE TIME OF "REMOVAL" AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1709082

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR