BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1190779 · Received September 24, 2008

    Report

    Report Number
    1644487-2008-02305
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT HAD EXPERIENCED 4-5 INTERMITTENT SHOCK-LIKE SENSATIONS WITH NO PATTERN IN THE UPPER CHEST AND THE REPORTER FELT THIS MAY MEAN "THERE MAY BE A FRAYED WIRE". ALL VNS DIAGNOSTICS TESTS WERE NORMAL. PER THE REPORTER, THE PT WILL HAVE VNS LEAD AND GENERATOR REVISION SURGERY IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 2802

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR