BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM

    MDR report key: 2944072 · Received January 31, 2013

    Report

    Report Number
    2024601-2013-00018
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    June 19, 2009
    Report Date
    January 4, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. BAND SLIPPAGE, PAIN, AND REFLUX ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE, REFLUX, AND PAIN AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTRO-ESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED WITH BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IF THERE IS TOTAL STOMA 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

    PT REPORTED ALLEGED LAP-BAND SYSTEM "SLIPPAGE", "PAIN", AND A PORT THAT "NEVER WORKED, NEVER HELD FLUID, AND WAS LEAKING." FOLLOW-UP INFORMATION: HEALTHCARE PROFESSIONAL REPORTED THE PT CAME IN TO THE OFFICE COMPLAINING OF REFLUX, FEELING TOO MUCH RESTRICTION, AND WAS "SORE." HEALTHCARE PROFESSIONAL ADDED THAT THE PT EXPERIENCED ABDOMINAL PAIN AFTER REMOVAL OF THE DEVICE, BUT THE SYMPTOM HAS RESOLVED. A "DISCREPANCY WITH VOLUME" DURING TWO ADJUSTMENTS WERE DOCUMENTED, BUT POSSIBILITY OF A LEAK WAS "NOT LOOKED INTO" OR CONFIRMED AS A DECISION HAD BEEN MADE TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43274 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM LTI ALLERGAN NA 1310036

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention