BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ACCESS PORT KIT (UNK SIZE)

    MDR report key: 2810012 · Received October 23, 2012

    Report

    Report Number
    2024601-2012-01105
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    June 15, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ABDOMINAL PAIN AND ADHESIONS ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. 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 PT'S CHART FOR TOTAL BAND VOLUME AND RECENT ADJUSTMENTS. IF RECENT ADJUSTMENTS HAVE NOT BEEN EFFECTIVE IN INCREASING RESTRICTION AND THE PT HAS BEEN COMPLIANT WITH NUTRITIONAL GUIDELINES, THE PT MAY HAVE A LEAKING BAND SYSTEM, OR MAY HAVE POUCH ENLARGEMENT OR ESOPHAGEAL DILATATION DUE TO STOMAL OBSTRUCTION, BAND SLIPPAGE OR OVER-RESTRICTION." "CAUTION: CARE MUST BE TAKEN DURING BAND ADJUSTMENT TO AVOID PUNCTURING THE TUBING WHICH CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ABDOMINAL PAIN AS FOLLOWS: "THERE WERE ADD'L OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN AND PORT SITE PAIN."

    Description of Event or Problem · 1

    PT INITIALLY REPORTED A "LAP-BAND RETURN." F/U INFO: PT NOTED AN ALLEGED "LEAK" WAS FOUND IN THE PORT, SO IT WAS "REVISED." THE LEAK WAS FIRST NOTED WHEN THE PT COULD "EAT ANYTHING" AND "DRINK ANYTHING." THE PT FELT NO RESTRICTION. FLUOROSCOPY AND ESOPHAGOGASTRODUODENOSCOPY (EGD) WERE PERFORMED. RESULTS SHOWED THE ALLEGED LEAK. F/U FINDINGS: HEALTH PROFESSIONAL REPORTED ADD'L INFO NOTING THE "PT PRESENTED WITH "LEFT UPPER QUADRANT ABDOMINAL PAIN" AND "INTRA-ABDOMINAL ADHESIONS IN THE LEFT UPPER QUADRANT OF OMENTUM ABOUT THE ANTERIOR ABDOMINAL WALL." THE PT WAS ALSO "GIVEN APPROX 30 CC'S OF BARIUM SULFATE TO DRINK AND THE ESOPHAGUS, STOMACH AND BAND IS EXAMINED UNDER X-RAY (FLUOROSCOPY) FOR DIAGNOSTIC PURPOSES." RESULTS SHOWED "PT HAS BUSTED PORT, NEEDS REVISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ACCESS PORT KIT (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention VITAMIN E| VITAMIN B-12| BIOTIN| BENEFIBER| MULTIVITAMINS