BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LA-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1910954 · Received November 23, 2010

    Report

    Report Number
    2024601-2010-00971
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. 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. INFECTION, DYSPHAGIA, OBSTRUCTION, IRRITATION/INFLAMMATION, AND PAIN 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 POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED." 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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN OBSTRUCTION AS FOLLOWS: "OBSTRUCTION OF STOMAS HAS BEEN REPORTED AS BOTH AN EARLY AND A LATE COMPLICATION OF THIS PROCEDURE. THIS CAN BE CAUSED BY EDEMA, FOOD, IMPROPER INITIAL CALIBRATION, BAND SLIPPAGE OR POUCH TORSION." "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 PAIN 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, 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF IRRITATION/INFLAMMATION AS FOLLOWS: "CONTRAINDICATION(S): 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."

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF "INFECTION, DYSPHAGIA, EPIGASTRIC DISCOMFORT, INFLAMMATION AND OBSTRUCTION". DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LA-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1491889

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R