BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1931194 · Received November 11, 2010

    Report

    Report Number
    2024601-2010-00883
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    August 13, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON (B)(4) 2010. 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 OR 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 A 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

    HEALTH PROFESSIONAL REPORTED AN ALLEGED "LEAK." THE DEVICE WAS FOUND TO HAVE A "LEAK" WHEN THE DOCTOR TRIED TO FILL THE PORT AND THERE WAS "NO RESTRICTION." THE DEVICE WAS REMOVED AND REPLACED. F/U FINDINGS: PER THE SURGEON, THE LOCATION OF THE ALLEGED LEAK ON THE DEVICE WAS IDENTIFIED AS: "THE TUBING, YOU CAN SEE A CRACK." THE SURGEON NOTICED THE ALLEGED LEAK AS FOLLOWS: "IT WAS THE CASE OF FILLING [THE] BAND AND THEN THE PT COMING IN A WEEK LATER AND NOTHING WAS THERE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 623405

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NONE REPORTED