BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3069647 · Received April 16, 2013

    Report

    Report Number
    2024601-2013-00274
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VOMIT 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 VOMIT AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF REFLUX AS FOLLOWS: "CONTRAINDICATIONS: THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: PATIENTS WITH INFLAMMATORY DISEASES OF THE GASTROINTESTINAL TRACT, INCLUDING SEVERE INTRACTABLE ESOPHAGITIS, GASTRIC ULCERATION, DUODENAL ULCERATION, OR SPECIFIC INFLAMMATION SUCH AS CROHN'S DISEASE." "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

    DOCTOR REPORTED EVENTS OF "INTRACTABLE VOMITING OR REFLUX" FROM JOURNAL ARTICLE: "REVISIONAL LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS FOLLOWING FAILED LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING", OBES SURG, DOI 10.1007/S11695-013-0888-0, PUBLISHED ONLINE 12/MAR/2013. THIS MEDWATCH REPRESENTS THE 5 PATIENTS LISTED IN TABLE 1 OF THE ARTICLE WHO WERE DIAGNOSED WITH "INTRACTABLE VOMITING OR REFLUX." ALTHOUGH THE MANUFACTURER OF THE DEVICE IS UNKNOWN, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164011 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R