BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3912772 · Received May 14, 2014

    Report

    Report Number
    2024601-2014-00259
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    November 25, 2012
    Report Date
    April 16, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTHOR OF THE ARTICLE WAS ASKED TO RETURN THE PRODUCT FOR A DEVICE ANALYSIS, AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. THIS INFORMATION WAS NOT MADE AVAILABLE TO 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. THE DEVICE WILL NOT BE RETURNED TO ALLERGAN. VISUAL EXAMINATION IS NOT POSSIBLE. FOLLOW UP WAS CONDUCTED, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN REPORTED WILL NOT BE RETURNED TO ALLERGAN REGARDING THE SERIAL NUMBER OR THE IMPLANT DATE.

    Description of Event or Problem · 1

    RECEIVED: "TECHNICAL REPORT: REINSTATING WEIGHT LOSS AFTER LEAKAGE FROM GASTRIC BANDS: A SIMPLE PULL-THROUGH TECHNIQUE TO REPLACE THE BROKEN BAND." AUTHOR: WILLIAM J. HAWKINS, MBCHB AND PAUL SUPER, MBBS. PUBLISHED IN "SURG LAPAROSC ENDOS PERCUTAN TECH - VOLUME 00, NUMBER 00, 2014 - WWW.SURGICAL-LAPAROSCOPY.COM, 2014 LIPPINCOTT WILLIAMS & WILKINS." THROUGH ALLERGAN PRODUCT WATCH. ARTICLE STATES: "PATIENT WHO HAD UNDERGONE GASTRIC BANDING AND SUBSEQUENT BAND EXCHANGE DUE TO A LEAK IN OUR UNIT BETWEEN 2006 AND 2010 WERE IDENTIFIED FROM OUR PROSPECTIVELY COLLECTED DATABASE." THIS RECORD CAPTURES THE SECOND OF TWO MENTIONED ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM DEVICES MENTIONED AS BEING ASSOCIATED WITH A LEAKAGE. FOLLOW UP WITH THE AUTHOR OF THE ARTICLE DID NOT LEAD TO ADDITIONAL INFORMATION. THE DEVICE RETURN HAD BEEN REQUESTED HOWEVER, PER THE REPORTER, THE DEVICE WILL NOT BE RETURNED TO ALLERGAN FOR A PRODUCT ANALYSIS SINCE THE REPORTED CASES ARE "HISTORICAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288247 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI