BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 3201748 · Received June 28, 2013

    Report

    Report Number
    2024601-2013-00552
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2013. 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 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 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 REPORTED EVENT OF INFLAMMATION AS FOLLOWS: "CONTRAINDICATIONS THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: PTS WITH INFLAMMATORY DISEASES OF THE GASTROINTESTINAL TRACT, INCLUDING SEVERE INTRACTABLE ESOPHAGITIS, GASTRIC ULCERATION, DUODENAL ULCERATION, OR SPECIFIC INFLAMMATION SUCH AS CROHN'S DISEASE." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED, "EROSION ASSOCIATED WITH THE LAP-BAND." THE BAND WAS REMOVED. FOLLOW-UP INFO: HEALTH PROFESSIONAL NOTED THAT PT HAD INITIALLY COMPLAINED OF DYSPHAGIA, SO FLUID WAS REMOVED. PT CAME BACK TO THE OFFICE FOR A CT SCAN, WHICH "SHOWED FLUID AND INFLAMMATION AROUND THE DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295816 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 2014983

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention LORTAB| PHENERGAN| ASPIRIN| SYNTHROID| LISINOPRIL| ATIVAN| LOTRISONE| RESTORIL| CATAPRES| ZOLOFT| LEVSIN