BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPBAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2142204 · Received May 26, 2011

    Report

    Report Number
    2024601-2011-00409
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. INADEQUATE WEIGHT LOSS IS A PHYSIOLOGICAL EVENT AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 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 PATIENTS TOTAL)." ALLERGAN DOES NOT GUARANTEE THAT EVERY PATIENT WILL ACHIEVE DESIRED WEIGHT LOSS.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT "THE BALLOON MAY HAVE BURST" AND THE PATIENT'S "WEIGHT LOSS HAS BEEN QUITE POOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPBAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention