BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1960362 · Received December 16, 2010

    Report

    Report Number
    2024601-2010-01012
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2010. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS BEEN DISCARDED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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

    PT REPORTED "TESTS SHOW THAT MY LAP-BAND LINE HAS SNAPPED AT THE JUNCTURE WHERE THE NIPPLE SPLICES THE BAND." THE PT STATED THAT THEIR SURGEON SAID,"THIS IS THE RESULT OF A DEFECTIVE BAND." FURTHER F/U WITH THE HEALTH PROFESSIONAL CONFIRMED THE EVENT AND THE EXPLANT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1642424

    Patients

    Seq Age Sex Outcome Treatment
    1