BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) NON US

    MDR report key: 1172874 · Received September 19, 2008

    Report

    Report Number
    2024601-2008-00733
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND 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 TO DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN UNBUCKLED BAND AS FOLLOWS: "FAILURE TO SECURE THE BAND PROPERLY MAY RESULT IN ITS SUBSEQUENT DISPLACEMENT OR NECESSITATE RE-OPERATION." "THE LAB-BAND 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."

    Description of Event or Problem · 1

    REPORTED AS: "PATIENT HAD AN AP SMALL (B-20260) INSERTED IN 2007. GOOD WEIGHT LOSS POST OP. APPROXIMATELY 9 MONTHS POST OP, IT WAS NOTED THAT THE PATIENT WAS GAINING WEIGHT. THE PATIENT WAS INVESTIGATED FOR A LOSS OF FLUID IN THE SYSTEM AS TO THE REASON FOR INCREASE WEIGHT GAIN, THE BAND WAS MAINTAINING FLUID SO THIS WAS EXCLUDED. ON GASTROSCOPY, IT LOOKED AS THOUGH THE BAND WAS OPEN. THE PATIENT WAS BOOKED FOR READMISSION AND REVISION OF BAND FOR 2008. IT WAS NOTED IN THIS REVISION THAT THE BAND WAS UNLOCKED. THE BAND WAS REMOVED AND REPLACED WITH AN AP SMALL. THE REMOVED BAND WILL BE RETURNED TO HEAD OFFICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) NON US DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1424375

    Patients

    Seq Age Sex Outcome Treatment
    1 NI