BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1860059 · Received September 17, 2010

    Report

    Report Number
    1644487-2010-02123
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    February 23, 2010
    Report Date
    August 18, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE MALFUNCTION IS SUSPECTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES AND HIGH LEAD IMPEDANCE WAS OBSERVED ON DIAGNOSTICS PERFORMED. IT IS UNCLEAR AT THIS TIME AS TO THE SPECIFIC CAUSE OF BOTH EVENTS. THE PATIENT IS EXPECTED TO HAVE LEAD AND GENERATOR REVISION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 8902

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR