BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1922098 · Received November 16, 2010

    Report

    Report Number
    2024601-2010-00903
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    February 16, 2007
    Report Date
    October 20, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED TO ALLERGAN. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINED ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT REC'D THE PRODUCT. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. INADEQUATE WEIGHT LOSS IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. DEVICE LABELING ADDRESS 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 POSSIBLE OUTCOME OF INADEQUATE WEIGHT LOSS AS FOLLOWS: "SEVENTY-FIVE SUBJECTS HAD THEIR ENTIRE LAP-BAND SYSTEM EXPLANTED. INSUFFICIENT WEIGHT LOSS WAS ALSO REPORTED AS A CONTRIBUTOR TO THE DECISION TO EXPLANT IN 24 OF THE 75 EXPLANTS (32%). (RECORDED AS OF DECEMBER 2000, CLINICAL STUDY, 299 PTS TOTAL)."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED REMOVING A LAP-BAND FOR "BRITTLE TUBING." FOLLOW-UP FINDINGS: "OVER A PERIOD OF TIME THE PT FELT NO RESTRICTION, WAS GAINING WEIGHT, AND HAD PROBLEMS MAINTAINING PRESSURE AND MAINTAINING ANY FILLS. AN UPPER GI (RADIOGRAPHY) WAS PERFORMED, AND SHOWED THAT THE BAND WAS IN GOOD POSITION, BUT NO RESTRICTION, SO THE SURGEON SUSPECTED A LEAK. HE EXPLANTED THE PORT AND REPLACED IT WITH A NEW PORT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NONE REPORTED