BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1932205 · Received December 14, 2010

    Report

    Report Number
    2024601-2010-01008
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON: (B)(4) 2010. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER AND THE EXACT IMPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED 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 WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE EXACT 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." "CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE."

    Description of Event or Problem · 1

    COMPANY REP REPORTED ON BEHALF OF A HEALTH PROFESSIONAL WHO STATED " I HAVE A PT WHO HAS A CONFIRMED LEAK IN THE TUBE... THE PT HAD BAND ADJUSTMENT UNDER FLUORO. SEVERAL SPOT IMAGES WERE OBTAINED DEPICTING PROGRESSIVE EXTRA-LUMINAL ACCUMULATION OF CONTRAST ABOUT THE MID PORTION OF THE CATHETER TUBING, CONSISTENT WITH TUBING LEAK. THE EXACT SITE OF CATHETER DISCONTINUITY COULD NOT BE IDENTIFIED." FURTHER F/U WILL BE CONDUCTED TO GATHER ADDITIONAL INFO.

    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