BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABEL GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2992396 · Received March 1, 2013

    Report

    Report Number
    2024601-2013-00115
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    October 1, 2010
    Report Date
    February 4, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS NOT REC'D THE PRODUCT. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. EROSION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN EROSION AS FOLLOWS: "THERE IS A RISK OF BAN EROSION INTO STOMACH TISSUE. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED. CAUTION: AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED "A PARTIAL LAP-BAND EROSION" WITH SUBSEQUENT SURGERY THAT OCCURRED ALREADY IN 2011. THE DEVICE IS NOT AVAILABLE FOR RETURN, AND THE SERIAL NUMBER IS UNK. THE PT SAW THE SURGEON IN 2010, FOR A BAND FILL ADJUSTMENT, BECAUSE THE BAND WAS TOO TIGHT". AN UPPER GI CONDUCTED "DIAGNOSED THE BAND EROSION." IN ADDITION, THE EROSION WAS "CONFIRMED VIA AN EGD". PER THE REPORTER, PT HAS "A HUGE MEDICAL HISTORY" AND HAD "AN EXPLORATORY LAPAROTOMY BECAUSE OF A SMALL BOWEL OBSTRUCTION (UNK DATE)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89921 LAP-BAND ADJUSTABEL GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PREVACID| LITHIUM| VASOTEC| CYMBALTA