BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 2151142 · Received June 21, 2011

    Report

    Report Number
    2024601-2011-00509
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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. 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."

    Description of Event or Problem · 1

    ALLERGAN REPRESENTATIVE REPORTED AN ALLEGED LEAK WAS FOUND IN A LAP-BAND DEVICE. UPON EXPLANT OF THE PORT, THE SURGEON SAW A "POLISHING OF TUBING" AND A "PIN HOLE" NEAR THE STRAIN RELIEF. THE SURGEON BELIEVES IT OCCURRED DUE TO "WEAR AND TEAR." THE PORT WAS REPLACED. FOLLOW-UP FINDINGS: THE SURGEON DETERMINED THAT "THE PATIENT WAS NOT LOSING WEIGHT." THE PATIENT EXPERIENCED "NO RESTRICTION" AND WAS "STARTING TO GAIN WEIGHT." "IT WAS DETERMINED THAT THERE WAS A LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM LTI ALLERGAN NA 1102233

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NONE REPORTED.