BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1963689 · Received December 21, 2010

    Report

    Report Number
    1644487-2010-02857
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    July 24, 2001
    Report Date
    November 22, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN (B)(4) WAS RECEIVED REPORTING THAT A VNS PT HAD EROSION OF LEAD SILICON SHEET OF THEIR FIRST DEVICE ((B)(6) 2001). NO ADVERSE EVENTS WERE REPORTED AND THE PT'S SEIZURES WERE INCREASED BUT REPORTED TO BE AT THEIR BASELINE RATE. GOOD FAITH ATTEMPTS ARE UNDERWAY TO DETERMINE WHAT EROSION OF THE SILICON SHEET MEANS. IT IS UNK IF THIS IS A EXTRUSION ISSUE THROUGH THE SKIN OR A DEVICE ISSUE AGAINST THE LEAD BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 632

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR