BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1841326 · Received September 13, 2010

    Report

    Report Number
    2024601-2010-00688
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED WITH THE LAP-BAND SYSTEM BY THE RPTR. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS REC'D THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE 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

    REC'D A VOICEMAIL MESSAGE FROM HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE. IN THE MESSAGE, HEALTH PROFESSIONAL SAID THEY HAVE A LAP-BAND TO RETURN TO ALLERGAN. NO ADD'L INFO WAS PROVIDED. F/U FINDINGS: PFN WAS SENT TO ALLERGAN WITH DEVICE. EVENT DESCRIPTION STATES: "GASTRIC BAND EXPLANT - VERY LARGE SLIP W/O EMPTYING THROUGH BAND."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention