BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2810029 · Received October 23, 2012

    Report

    Report Number
    2024601-2012-01086
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    December 5, 2011
    Report Date
    September 26, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. DYSPHAGIA 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 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

    HEALTH PROFESSIONAL REPORTED A LAP-BAND SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT DUE TO "PROGRESSIVE RECURRENT DYSPHAGIA." THE PT REPORTED TO THE PHYSICIAN "DIFFICULTY EATING MEAT" AND "POOR FOOD CHOICES." THE "SURGEON ADVISED TO REMOVE SOME FLUID FROM THE DEVICE AND THE PT REFUSED. THE PT WANTED TO WAIT A MONTH BEFORE FLUID WAS REMOVED AND THEN DID NOT COME BACK FOR THE NEXT APPOINTMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1756313

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention COUMADIN| XANAX| CRESTOR| ISOSORBIDE| FUROSEMIDE| BABY ASPIRIN| MULTI VITAMIN| NEXIUM| TYLENOL| TRICOR| VICODIN| LISINOPRIL| COREG| ALLOPURINOL