BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2003569 · Received February 22, 2011

    Report

    Report Number
    2024601-2011-00159
    Event Type
    Death
    Date Received
    February 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEATH, CANCER, OBSTRUCTION, AND DYSPHAGIA 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 REPORTED EVENT OF DEATH AS FOLLOWS: "LAPAROSCOPIC OR LAPAROTOMIC PLACEMENT OF THE LAP-BAND SYSTEM IS MAJOR SURGERY AND DEATH CAN OCCUR. PRECAUTIONS: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPLANT." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF 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, POUCH TORSION, OR PT NONCOMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." "PATIENTS MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PATIENTS WITH DENTURES MUST BE PARTICULARLY CAREFUL TO CUT THEIR FOOD INTO SMALL PIECES. FAILURE TO FOLLOW THESE PRECAUTIONS MAY RESULT IN VOMITING, STOMAL IRRITATION AND EDEMA, POSSIBLY EVEN OBSTRUCTION." "IF THERE IS TOTAL STOMAL OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATELY RE-OPERATION TO REMOVE THE BAND IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENT 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

    DOCTOR REPORTED EVENTS OF DEATH, "ESOPHAGEAL CARCINOMA", "OBSTRUCTING MASS", AND DYSPHAGIA FROM JOURNAL ARTICLE: "ESOPHAGEAL ADENOCARCINOMA AFTER LAPAROSCOPIC GASTRIC BAND PLACEMENT FOR OBESITY", DISEASES OF THE ESOPHAGUS (2011) 24, E8-E10. F/U INFO: THE DOCTOR STATED, ...I DO NOT FEEL THAT THE "ADVERSE EVENTS" MENTIONED IN THE ARTICLE HAD ANYTHING TO DO WITH ANY "FAILURE" OF THE DEVICE TO WORK AS INTENDED."

    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 66 YR Death