BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3900303 · Received May 6, 2014

    Report

    Report Number
    2024601-2014-00233
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER 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".

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A "LEAK". EVENT WAS NOTICED BY THE HEALTHCARE PROFESSIONAL DURING A FILL ATTEMPT WHERE LESS FLUID WAS FOUND IN THE DEVICE. FLUOROSCOPY WITH CONTRAST CONFIRMED THE "LEAK". THE DEVICE WAS REMOVED AND REPLACED. ADDITIONAL INFO: HEALTHCARE PROFESSIONAL REPORTED, "PORT WAS REPLACED DUE TO WEAR AND TEAR FROM THE HUBER NEEDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271677 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2042693

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR