BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1840141 · Received September 15, 2010

    Report

    Report Number
    2024601-2010-00766
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. FURTHER INFO FROM THE RPTR 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

    ALLERGAN SALES REPRESENTATIVE CALLED ON BEHALF OF AN EXPLANTING PHYSICIAN TO RETURN AN EXPLANTED LAP-BAND PORT AND TUBING THAT WERE REMOVED AND REPLACED, BECAUSE OF AN ALLEGED "LEAK." THE ALLEGED LEAK WAS CONFIRMED DURING A FLUOROSCOPY, BUT IT IS UNK THE EXACT LOCATION OF THE OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR