BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1172612 · Received September 19, 2008

    Report

    Report Number
    1644487-2008-02241
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE SUCCESSIVE INTRAOPERATIVE DIAGNOSTIC TESTS RESULTED IN HIGH LEAD IMPEDANCE WARNINGS, PROMPTING THE SURGEON TO USE A DIFFERENT LEAD. GOOD FAITH ATTEMPT FOR PRODUCT RETURN AND ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 UNK LYJ CYBERONICS, INC. 302-20 200772

    Patients

    Seq Age Sex Outcome Treatment
    1