BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1834460 · Received September 10, 2010

    Report

    Report Number
    2024601-2010-00741
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    April 29, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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

    HEALTH PROFESSIONAL CALLED TO REPORT A LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM THAT WAS REMOVED AND REPLACED, BECAUSE OF AN ALLEGED "COULDN'T GET THE PORT TO FILL." FURTHER FINDINGS: DURING AN APPOINTMENT THE PT HAD LITTLE RESTRICTION, EVEN THOUGH THEY HAD A FILL A WEEK BEFORE. A HEALTH PROFESSIONAL ACCESSED THE PORT AND WAS ONLY ABLE TO GET 1.8 CC'S OUT. FLUOROSCOPY IMAGING WAS DONE BY THE EXPLANTING DOCTOR. HE ACCESSED PORT WITH HUBER NEEDLE TO VERIFY LOCATION OF LEAK WITH SALINE. HE SAW POOLING OF SALINE TO RIGHT ANTERIOR, OUTSIDE OF THE BAND. CLARIFICATION: THE DOCTOR REPLACED THE BAND, BUT NOT THE PORT, JUST CONNECTED THE NEW BAND'S TUBING TO THE PORT. THE BAND IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1522185

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR