BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANLAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2844396 · Received November 5, 2012

    Report

    Report Number
    2024601-2012-01143
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    May 31, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, HOWEVER, THE DEVICE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. BASED UPON THE 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. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. PAIN AND INADEQUATE WEIGHT LOSS ARE SURGICAL/PHYSIOLOGICAL COMPLICATION AND AN ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." 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 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: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN AND PORT SITE PAIN." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INADEQUATE WEIGHT LOSS 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

    COMPANY REPRESENTATIVE REPORTED ON BEHALF OF HEALTH PROFESSIONAL, THE EXPLANT OF A LAP-BAND PORT DUE TO A "FULL TUBING BREAK." EVENT WAS FIRST NOTICED WHEN THE PATIENT REPORTED BEING "DISAPPOINTED WITH WEIGHT LOSS" AND "RIGHT LOWER QUADRANT ABDOMINAL PAIN." PORT WAS EXPLANTED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention LANTUS| TRICOR| MULTIVITAMINS| PAXIL| VITAMIN B| NOVOLOG| VITAMIN D