BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2890698 · Received December 26, 2012

    Report

    Report Number
    2024601-2012-01318
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    May 30, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. EROSION AND INFECTION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. EROSION OF THE BAND INTO STOMACH TISSUE HAS BEEN ASSOCIATED WITH REVISION SURGERY, AFTER THE USE OF GASTRIC IRRITATING MEDICATIONS, AFTER STOMACH DAMAGE AND AFTER EXTENSION 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 TO REMOVE THE DEVICE IS REQUIRED." "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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOW: "CONTRAINDICATIONS THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: PATIENTS WHO HAVE AN INFECTION ANYWHERE IN THEIR BODY OR WHERE THE POSSIBILITY OF CONTAMINATION PRIOR TO OR DURING THE SURGERY EXISTS." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AND EROSION AS FOLLOWS: (B)(4).

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LAP-BAND SYSTEM EXPLANT DUE TO EROSION. A "S/P SX [STATUS POST SURGERY] INFECTION" WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN BA 1713401

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention