BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1840046 · Received September 15, 2010

    Report

    Report Number
    1644487-2010-02090
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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 WHILE PERFORMING SYSTEM DIAGNOSTICS AT A F/U APPOINTMENT WITH THE TREATING NEUROLOGIST. THE PT'S DEVICE WAS NOT DISABLED AT THE TIME OF THE HIGH LEAD IMPEDANCE AND INFO FROM THE NEUROLOGIST INDICATED THAT SHE WAS NOT AWARE OF ANY PT TRAUMA OR MANIPULATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED HIGH LEAD IMPEDANCE. F/U WITH THE NEUROLOGIST'S OFFICE INDICATED X-RAYS WILL NOT BE TAKEN AND THE DEVICE WAS STILL ON. HOWEVER, THEY ARE AWARE THAT THE DEVICE SHOULD BE PROGRAMMED OFF IF A HIGH IMPEDANCE IS ENCOUNTERED. THE LAST KNOWN GOOD DIAGNOSTICS ACCORDING TO THE MFR'S PROGRAMMING HISTORY WERE FROM (B)(6) 2009 AND WERE OK/OK/3094/NO. SURGERY AT THE MOMENT IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 8861

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR