BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3111384 · Received May 9, 2013

    Report

    Report Number
    2024601-2013-00364
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    May 9, 2008
    Report Date
    April 16, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). 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 AND PT DATA. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE IMPLANT DATE THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THE REPORT. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. EROSION 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 ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. EROSION OF BAND INTO STOMACH TISSUE HAS BEEN ASSOCIATED WITH REVISION SURGERY, AFTER THE USE OF GASTRIC IRRITATING MEDICATIONS, AFTER STOMACH DAMAGE AFTER EXTENSIVE DISSECTION OR USE OF ELECTRO-CAUTERY, AND DURING EARLY EXPERIENCE. SYMPTOMS OF BAND EROSION MAY INCLUDE REDUCED WEIGHT LOSS, WEIGHT GAIN, ACCESS PORT INFECTION, OR ABDOMINAL PAIN." "RE-OPERATION FOR BAND EROSIONS MAY RESULT IN A GASTRECTOMY OF THE AFFECTED AREA. ERODED BANDS HAVE BEEN REMOVED GASTROSCOPICALLY IN A VERY FEW CASES, DEPENDING ON THE DEGREE OF EROSION. CONSULTATION WITH OTHER EXPERIENCED LAP-BAND SYSTEM SURGEONS IS STRONGLY ADVISED IN THESE CASES."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND SYSTEM EXPLANT DUE TO AN "EROSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204665 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention