BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP SYSTEM W/ACCESS PORT II

    MDR report key: 3220902 · Received June 25, 2013

    Report

    Report Number
    3220902
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ALLERGAN , INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THIS IS A PATIENT WITH A LAPAROSCOPIC ADJUSTABLE GASTRIC BAND WHO HAS HAD SUSPICION OF A LEAK FROM THE TUBING AS SHE FEELS NO RESISTANCE AND IS UNABLE TO MAINTAIN FLUID IN THE DEVICE.THE PATIENT ORIGINALLY HAD HER FIRST LAP-BAND PLACED IN MEXICO APPROXIMATELY SEVEN (7) YEARS AGO. SHE HAD THIS REPLACED APPROXIMATELY TWO (2) YEARS AGO IN ANOTHER CITY IN USA.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TUBING FOR LAP-BAND IN ORDER TO FILL BAND.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288950 LAP-BAND AP SYSTEM W/ACCESS PORT II IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ALLERGAN , INC. ACCESS PORT II *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR W/TUBING THAT WAS UNDER SUSPECT FOR A LEAK.| PATIENT HAD LAPAROSCOPIC ADJUSTABLE GASTRIC BAND