BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2040331 · Received February 15, 2011

    Report

    Report Number
    2024601-2011-00158
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE RPTR OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. THE INFO HAS NOT YET BEEN REC'D BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FURTHER INFO FROM THE RPTR REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE 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

    COMPANY REP REPORTED A PHYSICIAN "WAS UNABLE TO ASPIRATE FLUID FROM THE PT'S BAND AFTER INSERTING FLUID. USING FLUOROSCOPY, [THE PHYSICIAN] WAS ABLE TO VISUALIZE THAT CONTRAST HE INSERTED INTO THE PORT'S SEPTUM WAS SETTLING IN THE PT'S ABDOMEN. THE LAP-BAND TUBING IS IN 2 PIECES INTERNALLY WITH ONE END ATTACHED TO THE BAND AND ONE END ATTACHED TO THE PORT DISTALLY TO WHERE THE STAINLESS STEEL CONNECTION OCCURS. THE TUBING IS NO LONGER ATTACHED/CONNECTED IN ONE PIECE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI