BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL

    MDR report key: 1030367 · Received April 16, 2008

    Report

    Report Number
    1644487-2008-00936
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THE PT WAS ADMITTED TO THE HOSPITAL WITH STATUS EPILEPTICUS. SYSTEM TESTING SHOWED HIGH LEAD IMPEDANCE INDICATING A POSSIBLE LEAD MALFUNCTION. REVISION SURGERY WILL BE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL LYJ CYBERONICS, INC. 300-20 40408C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R