BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3223836 · Received July 10, 2013

    Report

    Report Number
    2024601-2013-00580
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2013. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL 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. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEHYDRATION AND INTOLERANCE 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 CONTRAINDICATION FOR PATIENTS REGARDING INTOLERANCE AS FOLLOWS: "CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PATIENT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPLANT." "THE LAP-BAND AP SYSTEM IS AVAILABLE IN TWO SIZES, SMALL AND LARGE. THE PHYSICIAN SHOULD CHOOSE THE APPROPRIATE SIZE DEPENDING UPON THE PATIENT'S INDIVIDUAL ANATOMY. AFTER RESOLUTION OF POSTOPERATIVE EDEMA, MOST PATIENTS WITH APPROPRIATELY PLACED BANDS REPORT MINIMAL IF ANY RESTRICTION UNTIL SALINE IS ADDED TO THE BAND, REGARDLESS OF THE SIZE USED." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DEHYDRATION 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

    HEALTHCARE PROFESSIONAL REPORTED AS "LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM WITH OMNIFORM DESIGN (SMALL) TOO TIGHT - REPLACED WITH LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM WITH OMNIFORM DISIGN (LARGE)." FOLLOW-UP FINDINGS: PATIENT ADMITTED TO HOSPITAL FOR DEHYDRATION AND IV STEROID THERAPY; BAND DEFILLED DAY AFTER BAND IMPLANTED. TWO DAYS LATER, PATIENT TO OPERATING ROOM FOR THE LAP-BAND SYSTEM TO BE UNBUCKLED DUE TO TIGHTNESS. THE 55 DAYS LATER CLOSURE OF DEVICE, DEFILLED IN RECOVERY STILL NOT TOLERATING FLUIDS; RETURNED TO OPERATING ROOM FOR BAND EXCHANGE FROM "LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM WITH OMNIFORM DESIGN (SMALL) TO LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM WITH OMNIFORM DESIGN (LARGE). NO BAND SLIPPAGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314955 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2401656

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R