BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1102004 · Received August 6, 2008

    Report

    Report Number
    1644487-2008-01788
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    April 28, 2008
    Report Date
    July 7, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REVIEW OF DIAGNOSTIC HISTORY FROM THE SITES HANDHELD COMPUTER REVEALED THAT THIS PATIENTS' DEVICE HAD HIGH LEAD IMPEDANCE FROM A SYSTEM DIAGNOSTIC TEST, END OF SERVICE STATUS WAS SET TO NO. REVIEW OF PROGRAMMING HISTORY INDICATES THAT THE DEVICE REMAINED ON WHEN THE HIGH LEAD IMPEDANCE WAS OBSERVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 6850C

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR