BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1854244 · Received September 3, 2010

    Report

    Report Number
    2024601-2010-00644
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    December 31, 2009
    Report Date
    July 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. PERFORMANCE TESTS INDICATE NO LEAKAGE AT THE ACCESS PORT OR ACCESS PORT TUBING. THE LAB WAS UNABLE TO DUPLICATE OR CONFIRM THE REPORTED EVENT. THERE IS NO OTHER INFO AVAILABLE AT THIS TIME FROM THE SURGEON TO DETERMINE THE CAUSE OF THE ALLEGED EVENT. DEVICE ANALYSIS NOTED THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT FOR REMOVAL OF THE DEVICE. DEVICE LABELING ADDRESS 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY." "MIGRATION OF THE BAND AND/OR TIPPING OF THE ACCESS PORT CAN OCCUR, RESULTING IN REDUCED WEIGHT LOSS, WEIGHT GAIN OR OTHER COMPLICATIONS, AND POSSIBLE RE-OPERATION TO REMOVE OR RE-POSITION THE DEVICE."

    Description of Event or Problem · 1

    RECEIVED A VOICEMAIL MESSAGE FROM HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE. IN THE MESSAGE, HEALTH PROFESSIONAL SAID THEY HAVE A LAP-BAND TO RETURN TO ALLERGAN. NO ADD'L INFO WAS PROVIDED. F/U FINDINGS: PFN WAS SENT TO ALLERGAN. EVENT DESCRIPTION STATES: "PORT EXPLANT." DURING ADJUSTMENT ATTEMPTS, DR WAS UNABLE TO ACCESS PORT FOR A FILL. CONFIRMED TO HAVE FLIPPED PORT. A REPLACEMENT WAS USED. THE ACCESS PORT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG LTI ALLERGAN NA 1219737

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR