BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2971853 · Received February 19, 2013

    Report

    Report Number
    2024601-2013-00069
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    July 18, 2012
    Report Date
    January 21, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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 AND PARTIAL IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO ADD¿L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. 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 DILATION DUE TO STOMAL OBSTRUCTION, BAND SLIPPAGE OR OVER-RESTRICTION.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT ¿DURING ADJUSTMENTS IT WAS NOTED THAT THE PATIENT WAS GAINING WEIGHT DESPITE SEVERAL BAND ADJUSTMENTS. SURGERY FOR BAND REPLACEMENT SCHEDULED BUT DURING SURGERY IT WAS NOTED THAT THE TUBING LEADING TO THE PORT WAS BRITTLE AND NOT CONTAINED. THE PORT WAS ALSO COMPLETELY [DISCONNECTED] FROM THE STAINLESS STEEL CONNECTOR. A NEW AP LARGE BAND WAS IMPLANTED. ALL OF THE PIECES OF THE PORT TUBING WERE REMOVED FROM THE PATIENT BEFORE CLOSING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72784 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention