BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GATRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3772217 · Received January 2, 2014

    Report

    Report Number
    2024601-2013-01065
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 2, 2013
    Report Date
    December 12, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    UDI-DI
    10811955020220
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON 04/10/2014. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER IL. THE DEVICE ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. IN ADDITION, THE ANALYSIS NOTED A THINNER SURFACE AND SMOOTH OPENING IN THE PORT TUBING CONSISTENT WITH WEAR AND TEAR. THERE WAS NO LEAKAGE NOTED IN THE ACCESS PORT. THE ANALYSIS ALSO NOTED AN OBSERVATION OF NEEDLE INDUCED SEAL DAMAGE TO THE ACCESS PORT. ADDITIONAL DEVICE LABELING- "WHEN ADJUSTING BAND VOLUME, TAKE CARE TO ENSURE THE RADIOGRAPHIC SCREEN IS PERPENDICULAR TO THE NEEDLE SHAFT (THE NEEDLE WILL APPEAR AS A DOT ON THE SCREEN) THIS WILL FACILITATE ADJUSTMENT OF NEEDLE POSITION AS NEEDED WHILE MOVING THROUGH THE TISSUE TO THE PORT WHEN ADJUSTING BAND VOLUME ONCE THE SEPTUM IS PUNCTURED, DO NOT TILT OR ROCK THE NEEDLE, AS THIS MAY CAUSE FLUID LEAKAGE OR DAMAGE TO THE SEPTUM WHEN ADJUSTING BAND VOLUME, USE OF AN INAPPROPRIATE NEEDLE MAY CAUSE ACCESS PORT LEAKAGE AND REQUIRE RE-OPERATION TO REPLACE THE PORT CAUTION: THE BAND, ACCESS PORT AND CALIBRATION TUBE MAY BE DAMAGED BY SHARP OBJECTS AND MANIPULATION WITH INSTRUMENTS."

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 07/01/2015.

    Additional Manufacturer Narrative · 1

    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 MODE 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. THE REPORTER OF THE EVENT ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE SEE SCANNED PAGE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LAP-BAND PORT HAD A "TINY HOLE" ON THE BUTTOM AND IT WAS "LEAKING". THE PATIENT FELT LIKE "NO ADJUSTMENTS WERE DONE" A FEW DAYS AFTER A PORT WA EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718 LAP-BAND AP ADJUSTABLE GATRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN N/A 2185393 10811955020220

    Patients

    Seq Age Sex Outcome Treatment
    1