BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2021807 · Received February 25, 2011

    Report

    Report Number
    1644487-2011-00353
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 22, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ABRADED INNER AND OUTER TUBINGS WITH FLUID PRESENT INSIDE OF INNER TUBING. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    DURING PRODUCT ANALYSIS FOR A VNS LEAD EXPLANTED DUE TO VNS THERAPY NO LONGER BEING DESIRED, IT WAS NOTED THAT THE LEAD BODY HAD ABRADED INNER AND OUTER TUBING. WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS WERE OBSERVED THROUGHOUT THE INSIDE OF THE OUTER SILICONE TUBING AND IN SOME AREAS OF THE INNER SILICONE TUBES. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. THE ELECTRODE ARRAY WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-30 20557C

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR