BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2191239 · Received July 19, 2011

    Report

    Report Number
    2024601-2011-00578
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    November 15, 2010
    Report Date
    June 21, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE 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. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE, OBSTRUCTION, NAUSEA AND VOMITING AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR, GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL." "IF THERE IS TOTAL STOMAL OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED." 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 THAT THE PATIENT ALLEGEDLY PRESENTED WITH NAUSEA AND VOMITING. THE BAND WAS DEFLATED AND AN UPPER GASTROINTESTINAL TEST INDICATED AN ALLEGED BAND SLIPPAGE AND OBSTRUCTION OF THE STOMACH. THE HEALTH PROFESSIONAL BELIEVES THE NAUSEA AND VOMITING WERE SECONDARY SYMPTOMS TO THE OBSTRUCTION. A REVISION SURGERY WAS PERFORMED TO REPOSITION THE BAND. NO PORTION OF THE SYSTEM WAS EXPLANTED. ABOUT SEVEN MONTHS AFTER THE SURGERY TO CORRECT THE SLIPPAGE, THE ENTIRE SYSTEM WAS EXPLANTED DUE TO AN ALLEGED BAND LEAK.

    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 37 YR Required Intervention