BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM

    MDR report key: 1061486 · Received June 16, 2008

    Report

    Report Number
    2024601-2008-00327
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II, THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. 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 DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FURTHER INFORMATION FROM THE REPORTER REGARDING SERIAL NUMBER HAS BEEN REQUESTED. 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."

    Description of Event or Problem · 1

    REPORTED AS A LEAK, "THE DOCTOR FOUND A FRACTURE IN THE TUBING COMING DOWN FROM THE BAND. THE DOCTOR WENT TO GRASP THE TUBING DURING A PORT REVISION, AND IT WAS BRITTLE AND KEPT BREAKING. THE DOCTOR IS GOING TO RE-SCHEDULE A SURGERY AND DO A FULL BAND WITH PORT REPLACEMENT ON ANOTHER DAY. ONLY THE PORT AND A FEW PIECES OF TUBING WERE EXPLANTED AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR