BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1930335 · Received November 24, 2010

    Report

    Report Number
    1644487-2010-02685
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 25, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING AN INCREASE IN SEIZURES AND HIGH IMPEDANCE WAS FOUND ON DIAGNOSTICS. X-RAYS WERE REVIEWED BY THE MFR AND NO ANOMALIES WERE VISUALIZED. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE. REVISION SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other