BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1172170 · Received September 17, 2008

    Report

    Report Number
    2024601-2008-00610
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. MEDWATCH SENT TO FDA ON 17/SEP/08: THE REPORTER OF THE COMPLIANT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, AS WELL AS, INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLIANT, BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE REPORTER REGARDING SERIAL NUMBER AND IMPLANT DATE 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."

    Description of Event or Problem · 1

    REPORTED AS: "OUR GROUP PERFORMED 1,256 LAPAROSCOPIC GASTRIC BANDINGS SINCE 1996, USING THE LAPBAND. WE DID A RETROSPECTIVE ANALYSIS ON COMPLICATIONS BETWEEN 2005 AND 2007. DURING THIS PERIOD 31 RE-INTERVENTIONS WERE PERFORMED FOR EITHER PORT (65%) OR BAND (35%) RELATED COMPLICATIONS. FOUR PATIENTS (13%) EXPERIENCED POSITIONAL PROBLEMS (DISLOCATION AND FLIPPING), IN 18 PATIENTS (58%), PROBLEMS AROSE FROM THE TUBE AND/OR TUBE-PORT CONNECTIONS, FIVE PATIENTS (19%), DEVELOPED AN INFECTION OF THE PORT, THREE PATIENTS (10%) EXPERIENCED SUBJECTIVE PROBLEMS SUCH AS PROMINENT VISIBILITY AND/OR DISCOMFORT." FROM LITERATURE REVIEW; JOURNAL ABSTRACT # 89 "PORT AND TUBE RELATED COMPLICATIONS IN LAPAROSCOPIC GASTRIC BANDING" S. PAULI, J. DERYCKER, M. VAN CLEEMPUT, DEURNE, BELGIUM; PUBLISHED IN "OBES SURG 2008" SPRINGER SCIENCE. THE FILE ADDRESSES ONE OF THE 18 COMPLAINTS OF LEAKAGE PROBLEMS THAT AROSE FROM THE TUBE AND/OR TUBE-PORT CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE OF TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1