BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1831825 · Received September 8, 2010

    Report

    Report Number
    1644487-2010-02043
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 THAT A PATIENT PRESENTED HIGH LEAD IMPEDANCE READINGS DURING A ROUTINE OFFICE VISIT. THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES THAT WAS BELOW PRE-VNS BASELINE LEVELS. THERE WAS NO TRAUMA OR MANIPULATION THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE PATIENT WAS PROGRAMMED OFF AND UNDERWENT FULL REVISION IN WHICH THE LEAD AND GENERATOR WERE REPLACED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AS WELL AS THE EXPLANTED PRODUCT FOR ANALYSIS 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 1391

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR