BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 1080097 · Received July 17, 2008

    Report

    Report Number
    2024601-2008-00379
    Event Type
    Injury
    Date Received
    July 17, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 17, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER TYPE II. MEDWATCH SENT TO FDA ON: 17/JUL/08. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. BAND SLIPPAGE, REFLUX, HERNIA, AND ESOPHAGEAL DILATATION 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 ESOPHAGEAL DILATATION AS FOLLOWS: ESOPHAGEAL DISTENSION OR DILATATION HAS BEEN REPORTED INFREQUENTLY. THIS IS MOST LIKELY A CONSEQUENCE OF INCORRECT BAND PLACEMENT, OVER-RESTRICTION, STOMA OBSTRUCTION, AND CAN ALSO BE, DUE TO EXCESSIVE VOMITING, OR PATIENT NON-COMPLIANCE, AND MAY BE MORE LIKELY IN CASES OF PRE-EXISTING ESOPHAGEAL DYSMOTILITY. DEFLATION OF THE BAND IS RECOMMENDED IF ESOPHAGEAL DILATATION DEVELOPS. A REVISION PROCEDURE MAY BE NECESSARY TO RE-POSITION OR REMOVE THE BAND IF DEFLATION DOES NOT RESOLVE THE DILATION. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE AND VOMITING 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."

    Description of Event or Problem · 1

    REPORTED BY THE PATIENT AS "A BAND SLIPPAGE CONFIRMED BY A BARIUM SWALLOW." FOLLOW UP WITH THE PATIENT REVEALS: "I HAVE REFLUX, A HIATAL HERNIA AND BAND SLIPPAGE WITH POUCH ENLARGEMENT." FOLLOW UP WITH THE DOCTOR REVEALS: "CONFIRMATION OF A HIATAL HERNIA, POUCH DILATATION (BAND SLIPPAGE) WITH SURGERY PENDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention