BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 3322381 · Received August 27, 2013

    Report

    Report Number
    2024601-2013-00731
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    July 31, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE CATALOG NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. EROSION, PAIN, AND AN ABSCESS ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. FOLLOW UP WITH SURGEON IN PROGRESS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RKS OF BAND 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ...ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN, AND ...PORT SITE PAIN."

    Description of Event or Problem · 1

    ALLERGAN REPRESENTATIVE REPORTED A LAP-BAND SYSTEM THAT WAS REMOVED DUE TO "EROSION AND A HUGE ABSCESS," FIRST NOTICED WHEN THE PATIENT "STARTED TO HAVE PAIN IN THE ABDOMEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418636 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention