BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2073716 · Received April 13, 2011

    Report

    Report Number
    1644487-2011-00802
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED TO OUR COUNTRY REPRESENTATIVE IN ARGENTINA THAT THEY HAD A VNS PT WITH HIGH LEAD IMPEDANCE ON THEIR SYSTEM AND NORMAL MODE DIAGNOSTIC TESTING. THE TEST WAS PERFORMED TWICE. NO SURGERY HAS BEEN PLANNED AT THIS TIME. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT. THE PT DOES NOT HAVE A CURRENT PHYSICIAN IN THEIR HOMETOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 200417

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female