BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2121855 · Received May 20, 2011

    Report

    Report Number
    2024601-2011-00370
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 5, 2010
    Report Date
    April 25, 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

    TAPER II. (B)(4). THE DEVICE HAS BEEN RECEIVED BY ALLERGAN BUT THE CONNECTOR TYPE HAS NOT BEEN CONFIRMED BY THE DEVICE ANALYSIS LAB. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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. 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

    THE EVENT IS REPORTED AS "PORT LEAKING. FLUID MISSING FROM PORT." THE ACCESS PORT WAS REMOVED AND REPLACED. FOLLOW-UP FINDINGS: SURGEON NOTED THE LEAKING WAS AROUND THE MEMBRANE UNDER HIGH PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1412771

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR PER SURGEON - NO CONCOMITANT THERAPY KNOWN.