BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNKNOWN SIZE)

    MDR report key: 1880987 · Received October 5, 2010

    Report

    Report Number
    2024601-2010-00838
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 15, 2009
    Report Date
    September 7, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON: (B)(4) 2010. THE REPORTER OF THE COMPLAINT WAS ASKED TO INDICATE THE PRODUCT SERIAL NUMBER. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER 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'S DEVICE ANALYSIS LAB RECEIVED A RETURN WITH A REPORT OF A BAND THAT WAS REMOVED BECAUSE THE PATIENT ALLEGEDLY WAS "UNABLE TO CONTINUE WEIGHT LOSS AND RESTRICTION." THE PATIENT PREVIOUSLY HAD A PORT REPLACEMENT, BUT WAS STILL NOT LOSING WEIGHT NOR FEELING RESTRICTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR