BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2240981 · Received August 17, 2011

    Report

    Report Number
    1644487-2011-01894
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 BY A NURSE THROUGH A COMPANY REPRESENTATIVE THAT HIGH LEAD IMPEDANCE (>10,000 OHMS) WAS ENCOUNTERED AT A FOLLOW-UP APPOINTMENT. THE PT RECENTLY HAD SURGERY ON (B)(6) 2011 AND WAS FIRST SEEN FOR DOSING WHEN THE HIGH IMPEDANCE WAS RECEIVED. THE PT WAS ABLE TO PERCEIVE STIMULATION EVEN THOUGH THERE WAS HIGH LEAD IMPEDANCE; HENCE THE DEVICE WAS NOT SWITCHED OFF. ADDITIONAL INFORMATION WAS RECEIVED FROM THE TREATING NURSE INDICATING THE LAST KNOWN GOOD DIAGNOSTICS WERE FROM AUGUST 1 AND IMPEDANCE WAS 3970 OHMS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REMAIN UNDERWAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR