BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2240830 · Received August 16, 2011

    Report

    Report Number
    2024601-2011-00638
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    April 15, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE RPTR THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE RPTR OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT REC'D THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE RPTR REGARDING THE SERIAL NUMBER OF THE DEVICE HAS BEEN REQUESTED. 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: "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."

    Description of Event or Problem · 1

    PT REPORTED ALLEGED ABDOMINAL PAIN AND LEAK WITH A LAP-BAND DEVICE. THE DEVICE WAS FOUND TO BE "SEPARATED INTO 2 PIECES" AFTER A CT (COMPUTERIZED TOMOGRAPHY) SCAN AND UPPER GI (GASTRO-INTESTINAL) RADIOGRAPHY WERE PERFORMED. THE PORT WAS REMOVED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention NONE REPORTED.