BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2041133 · Received March 29, 2011

    Report

    Report Number
    2024601-2011-00243
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS NOT EXPLANTED. THE REPORTER OF THE COMPLAINT WAS ASKED TO INDICATE THE PRODUCT SERIAL NUMBER. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. DISPLACEMENT IS A SURGICAL/PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY." "MIGRATION OF THE BAND AND/OR TIPPING OF THE ACCESS PORT CAN OCCUR, RESULTING IN REDUCED WEIGHT LOSS, WEIGHT GAIN OR OTHER COMPLICATIONS, AND POSSIBLE REOPERATION TO REMOVE OR REPOSITION THE DEVICE."

    Description of Event or Problem · 1

    DOCTOR REPORTED AN EVENT OF "PORT DISPLACEMENT". A LAP-BAND AP SYSTEM SURGICAL REVISION TOOK PLACE TO TREAT EVENT.

    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 31 YR Hospitalization| R