BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1781173 · Received July 29, 2010

    Report

    Report Number
    2024601-2010-00600
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    March 16, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE 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. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF A LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OF THE CONNECTOR TUBING." INADEQUATE WEIGHT LOSS IS A ADDRESSED IN THE LABELING: "ALLERGAN DOES NOT GUARANTEE THAT EVERY PT WILL ACHIEVE DESIRED WEIGHT LOSS."

    Description of Event or Problem · 1

    EVENT REPORTED IN OPERATIVE REPORT AS: "THE PT EXPERIENCED LOSS OF SATIETY AND COMPLAINED OF EXCESS LOWER ABDOMINAL SKIN AND SUBCUTANEOUS TISSUE." PT HAD GOOD RESULTS FROM PREVIOUS FOUR YEARS OF IMPLANT HISTORY. SURGEON PERFORMED ABDOMINOPLASTY WITH STANDARD PROFILE ACCESS PORT REPLACEMENT WITH LOW PROFILE ACCESS PORT. FOLLOW-UP FINDINGS: THE PROBLEM WAS OBSERVED WHEN THE PT COMPLAINED TO DR (B)(6) ABOUT LOSS OF SATIETY FROM THE LAP-BAND SYSTEM AND EXCESS LOWER ABDOMINAL SKIN AND SUBCUTANEOUS TISSUE. NO DIAGNOSTIC TESTING WAS DONE, HOWEVER, "ADJUSTMENTS WERE DONE AND FLUID WOULDN'T HOLD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR