BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300

    MDR report key: 1831953 · Received September 7, 2010

    Report

    Report Number
    1644487-2010-02039
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 12, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 HIGH LEAD IMPEDANCE WAS RECEIVED ON A VNS PATIENT AND WAS REFERRED FOR LEAD REPLACEMENT SURGERY. THE TREATING NEUROLOGIST REFERRED THE PATIENT FOR LEAD REPLACEMENT AND POSSIBLE GENERATOR REPLACEMENT AS THE UNIT HAD BEEN IMPLANTED SINCE 2008. FURTHER INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE INDICATING THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY AS SCHEDULED. FOLLOW-UP WITH THE TREATING NEUROLOGIST REVEALED THE HIGH IMPEDANCE WAS RECEIVED IN SYSTEM DIAGNOSTICS ON (B)(6) 2010 AND THE LAST KNOWN DIAGNOSTICS WERE FROM (B)(6) 2010. THERE WAS NO REPORTED PATIENT MANIPULATION OR TRAUMA THAT COULD HAVE HAD CONTRIBUTED TO THE HIGH LEAD IMPEDANCE AND NO X-RAYS WERE TAKEN. GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLANTED DEVICES RETURNED TO THE MANUFACTURER HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 3980

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR