BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1872132 · Received October 14, 2010

    Report

    Report Number
    1644487-2010-02307
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT HIGH LEAD IMPEDANCE WAS RECEIVED AT A FOLLOW-UP APPOINTMENT WITH THE TREATING NEUROLOGIST. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE TREATING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE. AT THE MOMENT THE PATIENT WAS REFERRED FOR FULL REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 4412C

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR