BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTMENT GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3122187 · Received May 17, 2013

    Report

    Report Number
    2024601-2013-00393
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    June 18, 2012
    Report Date
    April 9, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 CATALOG NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. PAIN, GASTROENTERITIS, NAUSEA, AND VOMIT ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENTS. DEVICE LABELING ADDRESSES THE ADVERSE EVENTS OF NAUSEA, PAIN, VOMITING, AND GASTROENTERITIS AS FOLLOWS: "PTS MUST BE CAREFULLY COUNSELED ON THE NEED TO REPORT ALL VOMITING, ABDOMINAL PAIN OR OTHER GASTROINTESTINAL OR NUTRITIONAL ISSUES AS THESE SYMPTOMS MAY INDICATE A CONDITION NOT RELATED TO THE LAP-BAND SYSTEM." "NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR A BAND/STOMACH SLIPPAGE. FREQUENT, SEVERE VOMITING CAN RESULT IN POUCH DILATATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION. DEFLATION OF THE BAND IS IMMEDIATELY INDICATED IN ALL OF THESE SITUATIONS. DEFLATION OF THE BAND MAY ALLEVIATE EXCESSIVELY RAPID WEIGHT LOSS AND NAUSEA AND VOMITING, OR RE-OPERATION TO REPOSITION OR REMOVE THE DEVICE MAY BE REQUIRED."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED "GASTRIC PROBLEMS, NAUSEA, VOMITING, AND PAIN" DUE TO THE LAP-BAND SYSTEM, FIRST NOTICED WHEN THE PT PRESENTED WITH "NAUSEA." DIAGNOSTIC TESTING FOUND THAT THE PT HAD GASTROENTERITIS. PT CONTINUED COMING IN FOR FOLLOW-UP APPOINTMENTS AND COMPLAINING OF ABDOMINAL PAIN, SO THE IMPLANTING PHYSICIAN REFERRED THE PT TO A GASTROENTEROLOGIST. HEALTH PROFESSIONAL NOTED THAT THE PT REPORTED TO THEIR IMPLANTING PHYSICIAN THAT THE GASTROENTEROLOGIST "REMOVED EVERYTHING OUT OF THE BAND." DEVICE REMAINS IMPLANTED. FOLLOW-UP INFORMATION: DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219556 LAP-BAND AP ADJUSTMENT GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1757724

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SYNTHROID| CARAFATE| METHADONE| MILK OF MAGNESIA| ZANTAC| XANAX| PRILOSEC| MULTI VITAMIN| VICOPROFEN