BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRI BANDING SYSTEM (UNK SIZE)

    MDR report key: 4172787 · Received October 10, 2014

    Report

    Report Number
    2024601-2014-00588
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE DEVICE HAS NOT BEEN COMPLETED AT THIS TIME. BAND SLIPPAGE, ESOPHAGEAL HERNIA, REFLUX, NAUSEA, AND VOMITING ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, DIAGNOSTIC TESTING AND ADDITIONAL PT DATA. THE BAND HAS BEEN IDENTIFIED AS EITHER A 9.75CM OR A 10.0CM BAND IN THE DEVICE ANALYSIS LAB.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED EXPLANT OF A LAP-BAND SYSTEM DUE TO "BAND SLIPPAGE". THE EVENT WAS FIRST NOTICED WHEN THE PT EXPERIENCED NAUSEA/VOMITING, GERD. THE LAP-BAND SYSTEM WAS EXPLANTED. FOLLOW-UP FINDINGS: PATHOLOGY REPORT NOTED, "LAP PARAESOPHAGEAL HERNIA REPAIR AND REMOVAL OF LAP-BAND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642656 LAP-BAND AP ADJUSTABLE GASTRI BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention