BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3760927 · Received April 9, 2014

    Report

    Report Number
    2024601-2014-00185
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 17, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. . THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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. FURTHER INFORMATION FROM THE REPORTER REGARDING THE STATUS OF THE DEVICE HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AND INFECTION 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 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 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 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

    COMPANY REPRESENTATIVE REPORTED A LAP-BAND FOR WHICH THE "BAND ERODED INTO STOMACH AND WAS INFECTED." THE LAP-BAND SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213269 LAP-BAND AP ADJUSTABLE GASRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention