BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN

    MDR report key: 1749766 · Received June 14, 2010

    Report

    Report Number
    1749766
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 14, 2010
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    THE VANGUARD GASTRIC BAND WAS PLACED THREE YEARS AGO. IT WAS FUNCTIONING APPROPRIATELY UNTIL LAST MONTH WHEN THE PT PRESENTED TO THE PHYSICIAN WITH INCREASING WEIGHT GAIN. LAST MONTH, SURGERY WAS PERFORMED AND IT WAS DETERMINED THAT THE BAND WAS DEFECTIVE. THE REVISION SURGERY WAS THEN ABORTED. ARRANGEMENTS WERE MADE TO REPLACE THE BAND. THE PT RETURNED AND HAD ANOTHER SURGERY LAST MONTH TO REPLACE THE GASTRIC BAND. A NEW DEVICE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN LAP BAND LTI ALLERGAN, INC. B-2250 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR