BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1854241 · Received September 30, 2010

    Report

    Report Number
    1644487-2010-02210
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (7/LIMIT/HIGH/NO) WAS RECEIVED AT A F/U APPOINTMENT WITH THE TREATING NEUROLOGIST. THE LAST KNOWN GOOD DIAGNOSTICS WERE FROM (B)(6) 2009 AND WERE WITHIN NORMAL LIMITS (NO SPECIFICS) AND DC DC 2. MOREOVER, THE PT IS REPORTED TO BE MRDD AND RECENTLY STARTED TO HAVE AN INCREASE IN SEIZURES. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING NEUROLOGIST 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 8521

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR