BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP SM W/RAPIDPORT EZ

    MDR report key: 3250098 · Received July 23, 2013

    Report

    Report Number
    2024601-2013-00693
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A RAPID PORT EZ STRAIN RELIEF. THE DEVICE ANALYSIS NOTED THAT THE PORT TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. THERE WAS NO LEAKAGE FROM THE ACCESS PORT. IN ADDITION, THE ANALYSIS NOTED PARTIALLY DEPLOYED ANCHORS OF THE ACCESS PORT WITH EXCESSIVE BIOLOGICAL TISSUE WITHIN THE ANCHOR PORT HOLES. FURTHERMORE, THE ANALYSIS NOTED BLUE DYE REMAINING ON THE REC'D TUBING THAT MAY INDICATE THE USAGE OF DYE FOR LEAK TESTING BY THE SURGEON. 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

    ALLERGAN REP REPORTED A LAP-BAND "PORT REPLACEMENT" WITH NO INFO REGARDING REASON FOR REPLACEMENT. ADD'L INFO: RETURN PAPERWORK NOTED THAT THE LAP-BAND SYSTEM WAS "MISSING FLUID ON SEVERAL OCCASIONS AND (HAD) MINIMAL RESTRICTION." PAPERWORK ALSO STATED THAT A "LEAK TEST" WAS PERFORMED AND REPLACED WITH "A NEW EZ PORT". THE REPORTED SERIAL NUMBER WAS FOUND TO BE INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343744 AP SM W/RAPIDPORT EZ LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR