BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3881646 · Received April 8, 2014

    Report

    Report Number
    2024601-2014-00192
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    January 15, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE DEVICE WAS NOT EXPLANTED. 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, IF IT IS EXPLANTED IN THE FUTURE. THE SURGERY HAS NOT OCCURRED, SO ALLERGAN HAS NOT RECEIVED THE DEVICE NOR PERFORMED ANALYSIS AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER.

    Description of Event or Problem · 1

    PATIENT REPORTED THEIR LAP-BAND SYSTEM "IS CRACKED OR LEAKING" AND ELABORATED THERE'S "A CRACK IN MY PORT." THE PROBLEM WAS FIRST OBSERVED WHEN THE PATIENT "HAD NO RESTRICTION" AND THEY "STARTED TO GAIN WEIGHT." THE PATIENT EXPLAINED THEY HAVE HAD FOUR FILLS, AND THE "LAP-BAND IS SUPPOSED TO HOLD 10 CC, BUT IT ONLY HAS ABOUT 2 CC SO SOMETHING IS GOING ON." THE LAP-BAND SYSTEM REMAINS IMPLANTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212306 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR CELEBREX| MULTIVITAMINS| SIMVASTATIN