BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 3897193 · Received May 21, 2014

    Report

    Report Number
    2024601-2014-00277
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. 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

    HEALTHCARE PROFESSIONAL REPORTED "LEAK FROM THE OLD LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (VG) WAS DUE TO COMPLETE BREAK IN THE TUBING - NOT ABLE TO USE EXISTING BAND - THE TUBING WAS TOO SHORT. NEW LA-BAND AP SYSTEM STANDARD W/ACCESS PORT II PLACED IN SITU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303349 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG LTI ALLERGAN NA 1292497

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO CONCOMITANT THERAPY PER FACILITY.