BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND

    MDR report key: 1672726 · Received April 13, 2010

    Report

    Report Number
    1672726
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 13, 2010
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A SUSPECTED LEAK IN THE ADJUSTABLE GASTRIC LAP-BAND SYSTEM. UNDER ANESTHESIA, THE BARIATRIC SURGEON REMOVED THE LAP-BAND FROM THE PT AND REPLACED IT WITH ANOTHER LAP-BAND PER THE PATIENT'S REQUEST. THE SURGEON DID CONFIRM THAT THERE WAS A LEAK IN THE TUBING WHICH CONNECTS TO THE PORT. THE ORIGINAL LAP-BAND WAS RETAINED AND SEQUESTERED FOR RISK MGMT. THE PT TOLERATED THE PROCEDURE WELL AND WAS SENT TO PACU FOR RECOVERY. UPON VISUAL INSPECTION, THERE WAS AN OBVIOUS HOLE NOTED IN THE TUBING ATTACHING THE PORT TO THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND IMPLANT, GASTRIC BAND, ADJUSTABLE SYSTEM LTI ALLERGAN, INC. 10 CM *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR