BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2770211 · Received October 1, 2012

    Report

    Report Number
    2024601-2012-00855
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    July 27, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED, NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER, AND IMPLANT DATE 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. 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 INITIALLY REPORTED "THE CATHETER [OF A LAP-BAND DEVICE] DISCONNECTED FROM THE PORT WHEN IT WAS BEING IMPLANTED." FURTHER INFORMATION WAS OBTAINED FROM THE HEALTH PROFESSIONAL THAT CLARIFIED THAT THE DEVICE WAS IMPLANTED AND AFTER AN ADJUSTMENT, THE PT REPORTED NO RESTRICTION. AN X-RAY CONFIRMED THE "CATHETER WAS DISCONNECTED." THE "PORT TUBING OTHER HAD BECOME DISCONNECTED FROM THE 'PORT TUBING SS.' THEIR CONNECTION APPEARED UNUSUALLY LOOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 2268794

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR LISINOPRIL