BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2191498 · Received July 20, 2011

    Report

    Report Number
    2024601-2011-00599
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT WAS NOT EXPLANTED NOR RETURNED WITH THE 2 TUBING PIECES BY THE REPORTER. BASED UPON THE MODEL STYLE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER, THE IMPLANT DATE AND THE PATIENT DATA HAS BEEN REQUESTED. THE SERIAL NUMBER INITIALLY REPORTED WAS A BREAST IMPLANT AND THE PAPERWORK RETURNED WITH THE DEVICE REFERRED TO IT AS A STERILIZATION RUN NUMBER. ADDITIONAL INVESTIGATION IN PROGRESS TO IDENTIFY THE DEVICE. 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 PATIENT'S CHART FOR TOTAL BAND VOLUME AND RECENT ADJUSTMENTS. IF RECENT ADJUSTMENTS HAVE NOT BEEN EFFECTIVE IN INCREASING RESTRICTION AND THE PATIENT HAS BEEN COMPLIANT WITH NUTRITIONAL GUIDELINES, THE PATIENT 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

    THE PATIENT COULDN'T LOSE WEIGHT WITH BAND, AND ADJUSTMENTS DOESN'T SEEM TO WORK. DURING EXAMINATION, IT SEEMS THAT THE TUBING WAS LEAKING. FOLLOW-UP FINDINGS: A TUBING REPAIR WAS PERFORMED. THE ORIGINAL APL LAP-BAND SYSTEM AND ACCESS PORT REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1