BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD

    MDR report key: 1061903 · Received June 16, 2008

    Report

    Report Number
    1644487-2008-01386
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    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

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A PT HAD HIGH LEAD IMPEDANCE READINGS. X-RAYS WERE REVIEWED BY THE MFR WHICH DID NOT IDENTIFY ANY LEAD DISCONTINUITIES. NO PT TRAUMA OR DEVICE MANIPULATION WAS ADMITTED. THE PT'S VNS HAS BEEN DISABLED. REVISION SURGERY IS PLANNED FOR 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD LYJ CYBERONICS, INC. 300-20 200241

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR