BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2153069 · Received June 29, 2011

    Report

    Report Number
    2024601-2011-00532
    Event Type
    Death
    Date Received
    June 29, 2011
    Date of Event
    November 17, 2009
    Report Date
    May 31, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE DATE OF THE SURGERY THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. DEATH AND HEMORRHAGE ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DEATH AS FOLLOWS: "LAPAROSCOPIC OR LAPAROTOMIC PLACEMENT OF THE LAP-BAND AP SYSTEM IS MAJOR SURGERY AND DEATH CAN OCCUR." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HEMORRHAGE AS FOLLOWS: "ADVERSE EVENTS: SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND."

    Description of Event or Problem · 1

    MEDIA ARTICLE REPORTED PT DEATH AFTER LAP-BAND IMPLANT PROCEDURE. F/U INFO: DEVICE NEVER IMPLANTED IN PT SO DEVICE IS EXONERATED.

    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 49 YR Death