BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3122154 · Received May 17, 2013

    Report

    Report Number
    2024601-2013-00465
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    July 28, 2010
    Report Date
    December 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON (B)(4) 2013. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. BASED ON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAM MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. POUCH DILATION, VOMITING, AND GASTROESOPHAGEAL REFLUX ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF POUCH DILATION AND VOMITING AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATION CAN OCCUR." "FREQUENT SEVERE VOMITING CAN RESULT IN POUCH DILATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION." "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF REFLUX 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

    HEALTH PROFESSIONAL REPORTED PT IN (B)(6) STUDY EXPERIENCED POUCH DILATION, VOMITING AND GASTROESOPHAGEAL REFLUX. A LAP-BAND AP SYSTEM REMOVAL TOOK PLACE TO TREAT EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219702 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1784125

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention GLIMEPIRIDE| VALSARTAN/HYDROCHLOROTHIAZIDE