BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2406921 · Received December 8, 2011

    Report

    Report Number
    2024601-2011-01068
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Date of Event
    February 23, 2010
    Report Date
    November 9, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. SINCE ALLERGAN HAS NOT YET RECEIVED THIS INFO, THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE EVENT OF LEAK AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT, OR THE CONNECTOR TUBING." "WHEN ADJUSTING BAND VOLUME, TAKE CARE TO ENSURE THE RADIOGRAPHIC SCREEN IS PERPENDICULAR TO THE NEEDLE SHAFT (THE NEEDLE WILL APPEAR AS A DOT ON THE SCREEN). THIS WILL FACILITATE ADJUSTMENT OF NEEDLE POSITION AS NEEDED WHILE MOVING THROUGH THE TISSUE TO THE PORT." "WHEN ADJUSTING BAND VOLUME ONCE THE SEPTUM IS PUNCTURED, DO NOT TILT OR ROCK THE NEEDLE, AS THIS MAY CAUSE FLUID LEAKAGE OR DAMAGE TO THE SEPTUM."

    Description of Event or Problem · 1

    REPORTED EVEN OF "TUBE DISCONNECTION" FROM JOURNAL ARTICLE: "OUTCOMES OF BARIATRIC SURGERY: CLINICAL BENEFITS VERSUS SHORT-TERM AND LONG-TERM COMPLICATIONS", NUTRITIONAL THERAPY & METABOLISM (2011) 29 (3): 124-133. MFR OF DEVICE IS UNK. IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING. THIS MEDWATCH REPRESENTS THE 1 CASE OF "TUBE DISCONNECTION" MENTIONED IN THE ARTICLE.

    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 NI Required Intervention