BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1171098 · Received September 18, 2008

    Report

    Report Number
    2024601-2008-00691
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON: 18/SEP/08. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT 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 INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. INFECTION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESS THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "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."

    Description of Event or Problem · 1

    REPORTED AS: "OUR GROUP PERFORMED 1,256 LAPAROSCOPIC GASTRIC BANDINGS SINCE JUNE 1996, USING THE LAPBAND. WE DID A RETROSPECTIVE ANALYSIS ON COMPLICATIONS BETWEEN JANUARY 2005 AND OCTOBER 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 CONNECTION 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, FOREIGN COUNTRY; PUBLISHED IN "OBES SURG 2008" SPRINGER SCIENCE. THIS FILE CAPTURES ONE OF THE FIVE REPORTED ALLEGED EVENTS OF: "DEVELOPED AN INFECTION OF THE PORT".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention