BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 1800146 · Received August 10, 2010

    Report

    Report Number
    1644487-2010-01832
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED; IMAGE QUALITY WAS VERY POOR. DEVISE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    RPTR INDICATED A RECENTLY IMPLANTED VNS PT HAD HIGH LEAD IMPEDANCE READINGS WITH DIAGNOSTICS TESTING. X-RAYS WERE REVIEWED BY THE MFR BUT THE POOR IMAGE QUALITY PREVENTED ASSESSMENT. ATTEMPTS FOR ADDITIONAL INFO AND PROGRAMING HISTORY ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1