BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 3040021 · Received April 1, 2013

    Report

    Report Number
    2024601-2013-00205
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    February 19, 2009
    Report Date
    March 6, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    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 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. INTOLERANCE, DYSPHAGIA, REFLUX, HIATAL HERNIA, ESOPHAGITIS AND BAND SLIPPAGE ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IS DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE, DYSPHAGIA, REFLUX AND INTOLERANCE AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTRO-ESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IF THERE IS TOTAL STOMA OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ESOPHAGITIS AND HIATAL HERNIA AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION, INFECTION, REDUNDANT SKIN, DEHYDRATION, GI PERFORATION, DIARRHEA, ABNORMAL STOOLS, CONSTIPATION, FLATULENCE, DYSPEPSIA, ERUCTATION, CARDIOSPASM, CARDIOSPASM, HEMATEMESIS, ASTHENIA, FEVER, CHEST PAIN, INCISION PAIN, CONTACT DERMATITIS, ABNORMAL HEALING, EDEMA, PARESTHESIA, DYSMENORRHEA, HYPOCHROMIC ANEMIA, BAND LEAK, CHOLECYSTITIS, ESOPHAGEAL DYSMOTILITY, ESOPHAGEAL ULCER, ESOPHAGITIS, PORT DISPLACEMENT, PORT SITE PAIN, SPLEEN INJURY AND WOUND INFECTION."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PATIENT "INTOLERANCE" TO THE LAP-BAND SYSTEM. "TWO YEARS AFTER IMPLANTATION, THE PATIENT PRESENTED WITH "DYSPHAGIA, HAD A PROLAPSE, AND A HIATAL HERNIA." THE HIATAL HERNIA WAS REPAIRED AND BAND WAS REPOSITIONED. FOUR MONTHS LATER, THE PATIENT PRESENTED WITH "DYSPHAGIA AND MILD ESOPHAGITIS" AND NO TREATMENT OCCURRED. ABOUT FOUR YEARS AFTER THE SURGERY TO REPAIR THE HERNIA AND BAND SLIP, THE PATIENT PRESENTED WITH "DIFFICULTY SWALLOWING, DYSPHAGIA, AND SEVERE REFLUX." THE PATIENT HAS NOT HAD A FILL ADJUSTMENT FOR ABOUT 3 YEARS AND 4 MONTHS. THE LAP-BAND SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131605 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1355144

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention PROPRANOLOL| A LOW DOSE ASPIRIN 81 MG| LEVOTHYROXINE| MULTIVITAMINS| CALCIUM