BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2915391 · Received January 9, 2013

    Report

    Report Number
    2024601-2012-01372
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE DEVICE WAS NOT EXPLANTED AT THIS TIME. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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.¿ DEVICE LABELING ADDRESSES THE FOLLOWING CONCERNS TO PERFORMING AN ADJUSTMENT: ¿PRIOR TO DOING AN ADJUSTMENT TO DECREASE THE STOMA, REVIEW THE PT¿S CHART FOR TOTAL BAND VOLUME AND RECENT ADJUSTMENTS. IF RECENT ADJUSTMENTS HAVE NOT BEEN EFFECTIVE IN INCREASING RESTRICTION AND THE PT HAS BEN COMPLIANT WITH NUTRITIONAL GUIDELINES, THE PT MAY HAVE A LEAKING BAND SYSTEM, OR MAY HAVE POUCH ENLARGEMENT OR ESOPHAGEAL DILATATION DUE TO STOMAL OBSTRUCTION, BAND SLIPPAGE OR OVER-RESTRICTION.¿

    Description of Event or Problem · 1

    ALLERGAN REPRESENTATIVE REPORTED SURGEON HAVING ISSUES WITH THE TUBING OF A LAPBAND SYSTEM. FOLLOW-UP INFORMATION: HEALTH PROFESSIONAL REPORTED THAT THE PT NOTED A LACK OF RESTRICTION. THE SURGEON PERFORMED A FLUOROSCOPY EXAMINATION AND RESULTS INDICATED THE TUBING CONNECTING THE FILL PORT TO THE BAND WAS ¿DEFECTIVE.¿ THE BAND IS NOT HOLDING FLUID AND THE SURGEON BELIEVES THE DEFECT CAUSING THE LEAK WILL BE KNOWN WHEN SURGERY IS PERFORMED. EXPLANT SURGERY IS NOT SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12334 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1803170

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR MULTIVITAMINS