BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1885102 · Received October 20, 2010

    Report

    Report Number
    2024601-2010-00829
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2010. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. IN ADDITION, ANALYSIS NOTED A SMOOTH OPENING IN THE PORT TUBING LIKELY CAUSED BY WEAR AND TEAR. THERE WAS LEAKAGE FROM THE DEVICE. 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

    HEALTH PROFESSIONAL REPORTED THE EXPLANTATION OF A LAP-BAND PORT. FOLLOW-UP FINDINGS: "THE PATIENT WAS HAVING FILLS, BUT THERE WAS NO RESTRICTION." UPPER GI (GASTROINTESTINAL) TESTING (RADIOGRAPHY) WAS DONE AND THE PORT WAS ALLEGEDLY FOUND TO HAVE LEAKAGE. THE DEVICE WAS EXPLANTED. NO INFORMATION WAS PROVIDED REGARDING IF THE PORT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1367885

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR