BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2926535 · Received January 17, 2013

    Report

    Report Number
    2024601-2013-00012
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    April 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION 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. MULTIPLE REQUESTS FOR FURTHER INFO HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. DEVICE LABELING: "PRECAUTION: CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY. FAILURE TO DO SO MAY RESULT IN THE INABILITY TO PERFORM PERCUTANEOUS BAND ADJUSTMENTS." "THE MFR OF THE LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM HAS DESIGNED, TESTED AND MANUFACTURED IT TO BE REASONABLY FIT FOR ITS INTENDED USE. HOWEVER, THE LAPBAND AP SYSTEM IS NOT A LIFETIME PRODUCT AND IT MAY BREAK OR FAIL, IN WHOLE OR IN PART, AT ANY TIME AFTER IMPLANTATION AND NOTWITHSTANDING THE ABSENCE OF ANY DEFECT. CAUSES OF PARTIAL OR COMPLETE FAILURE INCLUDE, WITHOUT IRRITATION, EXPECTED OR UNEXPECTED BODILY REACTIONS TO THE PRESENCE AND POSITION OF THE IMPLANTED DEVICE, RARE OR ATYPICAL MEDICAL COMPLICATIONS, COMPONENT FAILURE AND NORMAL WEAR AND TEAR. IN ADDITION, THE LAP-BAND AP SYSTEM MAY BE EASILY DAMAGED BY IMPROPER HANDLING OR USE. PLEASE REFER TO THE ADVERSE EVENTS SECTION IN THIS DOCUMENT AND TO THE INFO FOR PTS BOOKLET FOR A PRESENTATION OF THE WARNINGS, PRECAUTIONS, AND THE POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM."

    Description of Event or Problem · 1

    REPORTED EVENTS OF POUCH DILATATION, BAND SLIPPAGE, "FLUID LEAK FROM BAND", OBSTRUCTION, "BAND MALFUNCTION", INFECTION, EROSION, ESOPHAGEAL DILATATION FROM JOURNAL ARTICLE. "OUTCOMES OF REVISION LAPAROSCOPIC GASTRIC BANDING: A RETROSPECTIVE STUDY, ANZ JSURG.COM (2012). ALTHOUGH THE MFR OF THE DEVICE IS UNK, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING. THIS MEDWATCH REPRESENTS THE 6 PTS LISTED IN TABLE 2 OF THE ARTICLE AND THE 3 PTS LISTED IN TABLE 3 OF THE ARTICLE WHO EXPERIENCED "BAND MALFUNCTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25339 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI