BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1676301 · Received May 5, 2010

    Report

    Report Number
    2024601-2010-00319
    Event Type
    Injury
    Date Received
    May 5, 2010
    Date of Event
    September 1, 2008
    Report Date
    April 6, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO ALLERGAN BECAUSE IT WAS NOT EXPLANTED. BASED ON THE PROBABLE IMPLANT DATE, THE TAPER TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE. PAIN, NAUSEA, DEHYDRATION, INFECTION, AND HERNIA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF ABDOMINAL PAIN, DEHYDRATION, HERNIA, INFECTION, NAUSEA, AND OBSTRUCTION AS FOLLOWS: "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..." "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURE." "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA..." "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." "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED. NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR A BAND/STOMACH SLIPPAGE." "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." "IF THERE IS TOTAL STOMAL 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."

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF PAIN, NAUSEA, DIARRHEA, DEHYDRATION, "GRAM-POSITIVE PERITONITIS", "SMALL BOWEL OBSTRUCTION", "OMENTAL FAT HERNIA", AND "NECROTIC OMENTUM" FROM JOURNAL ARTICLE: "SMALL BOWEL OBSTRUCTION FROM SMALL BOWEL VOLVULUS AND GRAM-POSITIVE PERITONITIS IN LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING", SURGERY FOR OBESITY AND RELATED DISEASES 6 (2010) 211-212.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R