BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2191499 · Received July 20, 2011

    Report

    Report Number
    2024601-2011-00589
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    February 15, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4)/2011. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE FULL IMPLANT DATE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." DEVICE LABELING ADDRESSES THE FOLLOWING CONCERNS TO PERFORMING AN ADJUSTMENT: "PRIOR TO DOING AN ADJUSTMENT TO DECREASE THE STOMA, REVIEW THE PATIENT'S CHART FOR TOTAL BAND VOLUME AND RECENT ADJUSTMENTS. IF RECENT ADJUSTMENTS HAVE NOT BEEN EFFECTIVE IN INCREASING RESTRICTION AND THE PATIENT HAS BEEN COMPLIANT WITH NUTRITIONAL GUIDELINES, THE PATIENT MAY HAVE A LEAKING BAND SYSTEM, OR MAY HAVE POUCH ENLARGEMENT OR ESOPHAGEAL DILATATION DUE TO STOMAL OBSTRUCTION, BAND SLIPPAGE, OR OVER-RESTRICTION."

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE ACCESS PORT WAS EXPLANTED AND REPLACED THREE WEEKS AGO. THE SURGEON TOLD THE PATIENT THAT THE PORT WAS DEFECTIVE. THE PROBLEM WAS FIRST OBSERVED WHEN THE PATIENT EXPERIENCED "NO RESTRICTION." THE IMPLANTING SURGEON WOULD ADD FLUID AND KEEP ADDING FLUID, BUT NEVER CHECKED THE FLUID. THE EXPLANTING SURGEON, PRIOR TO SURGERY, FILLED THE BAND, BUT THE FLUID WOULD JUST LEAK OUT. NO DIAGNOSTIC TESTING WAS PERFORMED. FOLLOW-UP FINDINGS: THE EXPLANTING SURGEON FOUND A "CRACK ON THE POSTERIOR" SIDE OF "THE PORT" AT EXPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR