BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3800560 · Received February 11, 2014

    Report

    Report Number
    2024601-2014-00043
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    November 15, 2013
    Report Date
    January 13, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AM
    Reporter Occupation
    PHYSICIAN

    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 SERIAL NUMBER AND 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 REC'D THE DEVICE NOR PERFORMED ANALYSIS AT THIS TIME. 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

    IMPLANTING PHYSICIAN REPORTS EVENT AS "ONE AND A HALF YEARS AGO LAP-BAND WAS IMPLANTED. RECENTLY FAILURE OF THE ACCESS PORT IS DISCOVERED." DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90010 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 2296984

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR