BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3142948 · Received May 30, 2013

    Report

    Report Number
    2024601-2013-00423
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WAS RETURNED HOWEVER THE DEVICE ANALYSIS RESULTS ARE PENDING AT THIS TIME. SINCE THE REPORTER DID NOT PROVIDE THE SERIAL NUMBER OF THE DEVICE AND/OR THE IMPLANT DATE, THE CONNECTOR TYPE CANNOT BE DETERMINED AT THIS TIME. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. OBSTRUCTION, BAND SLIPPAGE, AND REFLUX (REGURGITATION) ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE REPORTED EVENTS 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 BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IF THERE IS TOTAL STOMAL OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THE DOCTOR "REMOVED AND REPLACED A PTS' LAP-BAND AND PORT" DUE TO A "SLIPPED LAP-BAND." THE "PT [PATIENT HAD BEEN INITIALLY] ADMITTED TO HOSPITAL AND DISCHARGED, BUT COULD NOT EAT OR DRINK [REQUIRED ADDITIONAL INTERVENTION]."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237885 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R NONE REPORTED.