BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3193299 · Received June 25, 2013

    Report

    Report Number
    2024601-2013-00542
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 PHOTO OF THE EXPLANTED PORT 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. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE IMPLANT DATE, PATIENT DATA OR FURTHER EVENT DETAILS. 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

    PHYSICIAN REPORTED A SUSPECTED PORT LEAK WHEN PATIENT WAS NOT EXPERIENCING SATIETY AND BAND KEPT REQUIRING FILLS. WAS NOT CONFIRMED UNTIL SURGERY WITH DIRECT VISUALIZATION. BACK PLATE HAD COME AWAY FROM PORT HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287451 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 2044963

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR