BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1222462 · Received November 4, 2008

    Report

    Report Number
    2024601-2008-00829
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 11/04/2008. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. BAND SLIPPAGE, POUCH DILATION AND REFLUX 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 SLIPPAGE AS FOLLOWS: "OVER DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "THE DISSECTION SHOULD BE THE SAME SIZE AS THE BAND OR EVEN SMALLER TO REDUCE THE POSSIBILITY OF BAND AND/OR STOMACH SLIPPAGE." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    REPORTED ON A SAE CLINICAL FORM AS: "GASTRIC PROLAPSE. THE SUBJECT'S ANNUAL ROUTINE ESOPHAGRAM SHOWED A HORIZONTAL BAND SLIP WITH A LARGE POUCH." THE PATIENT HAS HAD REFLUX CONTROLLED BY ZANTAC MEDICATION. ADDITIONAL FINDINGS: REVISION SURGERY OCCURRED TO REPOSITION THE DEVICE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1419023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention