BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 3123870 · Received May 15, 2013

    Report

    Report Number
    2024601-2013-00405
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    August 16, 2012
    Report Date
    April 15, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AND WAS DISCARDED AFTER SURGERY BY THE REPORTER. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. 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 A LAP-BAND SYSTEM "BAND" LEAK. THE LEAK WAS FIRST NOTED WHEN "THE PORT WAS ACCESSED WITH A HUBER NEEDLE AND THERE WAS NO FLUID IN ASPIRATED." DURING EXPLANT SURGERY, "THE PORT WAS EXTERNALIZED. NO OBVIOUS LEAK IN THE PORT WAS NOTED TO BE PRESENT. IT WAS ACCESSED, AND UNDER METHYLENE BLUE WAS INSTILLED AND WE SAW LEAKAGE FROM THE BAND AREA." IT WAS ALSO NOTED THAT "WE COULD NOT SEE THE HOLE, BUT WE COULD SEE THE EXTRAVASATION OF METHYLENE BLUE." THE LAP-BAND SYSTEM WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215014 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR