BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2191241 · Received July 19, 2011

    Report

    Report Number
    2024601-2011-00588
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE 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. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER OF THE DEVICE 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

    PATIENT REPORTED AN ALLEGED "LEAK" WITH A LAP-BAND DEVICE. THE DEVICE WAS FOUND TO HAVE A "LEAK" WHEN THE DOCTOR PERFORMED A BARIUM SWALLOW. THE LOCATION OF THE LEAK COULD NOT BE DETERMINED. THIS EVENT WAS FIRST NOTICED WHEN THE PATIENT WENT IN FOR A FILL ADJUSTMENT AND THERE WAS NO RESTRICTION. SURGERY HAS BEEN SCHEDULED FOR THE DEVICE TO BE "REPAIRED." THE PATIENT HAS DECLINED PERMISSION FOR ALLERGAN TO CONTACT THE PHYSICIAN.

    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 56 YR NONE REPORTED.