BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 3123853 · Received May 15, 2013

    Report

    Report Number
    2024601-2013-00370
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    August 15, 2012
    Report Date
    April 22, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CAUTION: CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY. FAILURE TO DO SO MAY RESULT IN THE INABILITY TO PERFORM PERCUTANEOUS BAND ADJUSTMENTS."

    Description of Event or Problem · 1

    PT REPORTED THEIR LAP-BAD SYSTEM "IS NOT HOLDING ANY FLUID" FIRST NOTICED WHEN THE PT REPORTED BEING "ABLE TO CONSUME MORE FOOD." HEALTHCARE PROFESSIONAL REPORTED THE LEAK WAS FIRST NOTED WHEN THE PHYSICIAN WAS NOT ABLE TO "PULL BACK THE AMOUNT OF FLUID" THAT WAS SUPPOSED TO BE IN THE DEVICE. A "FILL UNDER FLUOROSCOPY ON (B)(6) 2013" SHOWED A "PROBABLE LAP-BAND PORT LEAK AND MALPOSITION." THE "PORT IS SITTING SIDEWAYS" AND THERE IS NO INDICATION WHAT CAUSED THE PORT DISPLACEMENT. THE PORT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214988 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1290027

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR