BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2891226 · Received December 21, 2012

    Report

    Report Number
    2024601-2012-01299
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    April 1, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE 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 OR MODEL 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

    PATIENT REPORTED "BROKEN TUBING" WITH A LAP-BAND SYSTEM. THE EVENT WAS FIRST NOTED WHEN THE PATIENT EXPERIENCED NO RESTRICTION, STARTED FEELING HUNGRY, THE BAND WOULDN'T TAKE FILLS, AND [THE PATIENT'S] CHOLESTEROL INCREASED. THE PHYSICIAN "INJECTED DYE INTO THE PORT AND SAW FLUID LEAKING RIGHT OUT." THE DEVICE REMAINS IMPLANTED AND EXPLANT SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR