BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2945101 · Received January 31, 2013

    Report

    Report Number
    2024601-2013-00040
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 5, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER AND EXPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE BAND'S DESCRIPTION PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAM MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER, THE EXACT EVENT DATE, EXACT IMPLANT DATE, EXPLANT DATE, PT DATA OR FURTHER EVENT DETAILS. AT THIS TIME, ALLERGAN DOES NOT KNOW IF THE DEVICE HAS BEEN EXPLANTED. 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

    SURGEON REPORTED, "I MADE AN IMPLANT OF A LARGE LAP-BAND ABOUT 45 DAYS AGO AND IT'S ADJUST WAS MONITORED BY SERIOGRAPHY (EED) AFTER 30 DAYS AND ON THE POSTOPERATIVE INSPECTION, BUT I NOTICED THAT, ABOUT 5-7 DAYS AFTER THE ADJUSTMENT, PT REPORTED A LOSS OF RESTRICTION MECHANISM. THIS IS THE REASON THAT I AM MAKING SOME "ADJUSTMENTS" MONITORED BY SERIOGRAPHY, BUT THEY WERE ALWAYS UNSUCCESSFUL." PHYSICIAN ALSO REPORTED TO HAVE CONDUCTED A TEST WITH CONTRAST AND A "TIRE FITTER" (SIC) TEST." INVESTIGATION IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42380 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI