BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3874092 · Received May 29, 2014

    Report

    Report Number
    2024601-2014-00298
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 15, 2013
    Report Date
    May 6, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P00008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTHOR OF THE ARTICLE WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF SO AVAILABLE, AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. THIS INFO 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. BAND SLIPPAGE AND EROSION ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND AN ANALYSIS OF A THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE OF THESE EVENTS. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    RECEIVED ARTICLE, THROUGH ALLERGAN PRODUCT WATCH: "CURRENT HEALTH SCIENCES JOURNAL VOL. 39, NO. 2, 2013 APRIL JUNE, CASE REPORT, INTRAJEJUNAL MIGRATION OF ADJUSTABLE GASTRIC BAND: A CASE REPORT, BY K SAPALIDIS, L LIAVAS, N PANTELI, E KOSMATOPAOULOS, I. ANASTASIADIS, S CHARALAMBIDES, I KESISOGLOU, N TZIRIS, 3RD DEPT OF SURGERY, AHEPA UNIVERSITY OF THESSALONIKI, THESSALONIKI, GREECE". ARTICLE MENTIONED: "CASE PRESENTATION. WE REPORT A RARE CASE OF INTRAJEJUNAL MIGRATION OF AN ADJUSTABLE GASTRIC BAND THAT WAS PLACED LAPAROSCOPICALLY FOUR YEARS AGO." PER THE ARTICLE: "IN OUR CASE, LAPAROTOMY WAS OUR ONLY OPTION, AS THE GASTRIC BAND WAS MIGRATED AND FIXED INTO JEJUNUM, CAUSING OBSTRUCTION AND JEJUNOJEJUNAL FISTULAE, MAKING THE ENDOSCOPIC REMOVAL OF THE NAD IMPOSSIBLE. THE PT TOLERATED THE SURGERY WELL AND HAD AN UNEVENTFUL POST-OP PERIOD. [THE PT] WAS DISCHARGED ON THE NINTH POST-OP DAY." THE DEVICE HAS NOT BEEN CONFIRMED AS A DEVICE MANUFACTURED BY ALLERGAN, HOWEVER ALLERGAN'S APPROACH TO REPORTING ADVERSE EVENTS IS TO REMOVE ALL DOUBT IN FAVOR OR REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316875 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention