BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2875254 · Received December 13, 2012

    Report

    Report Number
    2024601-2012-01270
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THE REPORTER DECLINED TO RETURN THE PRODUCT. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. PAIN IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 INCREASINGLY 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "THERE WERE ADDITIONAL 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

    HEALTH PROFESSIONAL REPORTED A LAP-BAND PORT "LEAK." THE PATIENT FIRST STARTED EXPERIENCING LOSS OF RESTRICTION AND WEIGHT GAIN FOR ABOUT THE LAST YEAR. THE DOCTOR PERFORMED A SERIES OF ADJUSTMENT FILLS, BUT THE PATIENT WAS STILL EXPERIENCING A LOSS OF RESTRICTION AND WEIGHT GAIN. THE PORT WAS EXPLANTED AND REPLACED. FOLLOWING THE REPLACEMENT, PATIENT EXPERIENCED "SEVERE ABDOMINAL PAIN" AND THE DOCTOR FOUND THAT THE "TUBING HAD BROKEN IN TWO PIECES." A CT (COMPUTED TOMOGRAPHY) UROGRAM AS WELL AS IN UPPER GI (GASTROINTESTINAL) WERE CONDUCTED AND THE SURGEON WAS NOT ABLE TO DETERMINE THE PROBLEM OR LOCATION OF THE PROBLEM. THE SURGEON PERFORMED SURGERY AND DURING SURGERY OBSERVED THE TUBING WAS BRITTLE. THE SURGEON SLICED AND SPLICED THE TUBING TOGETHER TO FIX THE PROBLEM. TUBING WAS REPAIRED AND REMAINS IMPLANTED. HEALTH PROFESSIONAL REPORTED THE PHYSICIAN NOW BELIEVES THERE WAS NOTHING WRONG WITH THE PREVIOUSLY EXPLANTED PORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention