BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1083082 · Received July 23, 2008

    Report

    Report Number
    2024601-2008-00386
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 21, 2008
    Report Date
    June 23, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE PRODUCT ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED AT THIS TIME. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AFTER COMPLETION OF EXPLANT SURGERY AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED ON THE REPORTED MODEL (VG) OF THE LAP-BAND SYSTEM THE CONNECTOR TYPE IS ASSUMPTION TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AFTER COMPLETION OF THE EXPLANT SURGERY. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. 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."

    Description of Event or Problem · 1

    REPORTED (BY PT) AS A "LEAKING LAPBAND." DEVICE REMAINS IMPLANTED AT THIS TIME. PT WILL SEE MD AGAIN TO SCHEDULE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI