BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1880988 · Received October 5, 2010

    Report

    Report Number
    2024601-2010-00827
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    June 9, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. THE CONNECTOR TYPE CANNOT BE IDENTIFIED, NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE REPORTED 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

    DOCTOR REPORTED EVENT OF ¿LAP BAND LEAK¿ FROM JOURNAL ARTICLE: ¿BARIATRIC SURGERY OUTCOMES IN PATIENTS AGED 65 YEARS AND OLDER AT AN AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY CENTER OF EXCELLENCE,¿ OBES SURG (2010) 20:1199-1205. ALLERGAN¿S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    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