BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1931192 · Received November 11, 2010

    Report

    Report Number
    2024601-2010-00887
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED PULLED AND MISSING MATERIAL FROM THE DAMAGED PORT SEPTUM AND EVIDENCE OF CORING LIKELY TO BE CAUSED BY THE USE OF A CORING NEEDLE. IN ADDITION, ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN AND STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. BAND SLIPPAGE, VOMITING, PAIN, AND REFLUX ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 REPORTED EVENT OF BAND SLIPPAGE, VOMITING AND REFLUX AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY HAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF 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, DEHYDRATION, CHEST PAIN, INCISION PAIN, AND PORT SITE PAIN."

    Description of Event or Problem · 1

    MEDICAL STAFF REPORTED A LAP-BAND ACCESS PORT HAD BEEN EXPLANTED. F/U FINDINGS: THE PROBLEM WAS FIRST DISCOVERED WHEN THE "PT WAS GAINING WEIGHT BACK. ALL FLUID WAS TAKEN OUT BUT THE PT STILL EXPERIENCED ACID REFLUX, FELT TIGHTNESS WITH PAIN AND VOMITING, THE DOCTOR DID AN UPPER GI" WHICH CONFIRMED A LEAK AND THE BAND SLIPPAGE. THE ENTIRE DEVICE WAS REPLACED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1509605

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention NONE REPORTED