BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2122089 · Received May 24, 2011

    Report

    Report Number
    2024601-2011-00412
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    January 15, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. 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 BEEN 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

    EVENT WAS REPORTED AS "PATIENT WAS NOT FEELING RESTRICTION AFTER SEVERAL FILLS. WE ASPIRATED SEVERAL TIMES AND FOUND THAT SYSTEM WAS NOT HOLDING SALINE." THE PORT WAS EXPLANTED AND REPLACED. THE SURGEON NOTED LEAK WAS AT THE PORT HOUSING AND A "SEAL LEAK" WAS OBSERVED. THE DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1838139

    Patients

    Seq Age Sex Outcome Treatment
    1