BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2240828 · Received August 16, 2011

    Report

    Report Number
    2024601-2011-00641
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    December 1, 2010
    Report Date
    July 22, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE RPTR OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT REC'D THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE RPTR REGARDING THE SERIAL NUMBER OF THE DEVICE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    PT REPORTED THE REMOVAL OF HER LAP-BAND SYSTEM DUE TO AN ALLEGED "LEAK." THE PT STATED THAT THEY HAD NOTICED A LACK OF RESTRICTION FOR ABOUT A YR BEFORE THE DEVICE WAS EXPLANTED. THE BAND WAS FOUND TO BE LEAKING. F/U FINDINGS: THE SURGEON REPORTED THAT THE PT "DID WELL FOR A YR." AFTER THAT THE PT WOULD "HAVE RESTRICTION FOR A WEEK" AND THEN "LOSE IT FOR A MONTH." THEY NEVER FOUND THE SAME AMOUNT OF FLUID IN THE BAND DURING FILL APPOINTMENT. AN "UPPER GI COULDN'T CONFIRM THE LEAK," BUT FOUND THAT LESS CCS CAME OUT OF THE BAND AFTER MORE CCS WERE PUT IN. DURING EXPLANT, THE SURGEON INJECTED THE PORT AND SAW THE LEAK COME OUT OF THE BALLOON OF THE BAND. THE SURGEON HAD TO CUT THE BAND TO GET IT OUT, AND WAS UNSURE WHERE THE EXACT LOCATION OF THE LEAK WAS ON THE BALLOON. THE ENTIRE SYSTEM WAS REPLACED.

    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 LEVOTHYROXINE