BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1111872 · Received August 12, 2008

    Report

    Report Number
    1644487-2008-01668
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 14, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    MFR IMPLANT CARD WAS RECEIVED INDICATING THAT LEAD A GENERATOR REPLACEMENT SURGERY OCCURRED DUE TO LEAD DISCONTINUITY. DIAGNOSTICS PERFORMED SIX MOS BEFORE SURGERY INDICATED PROPER DEVICE FUNCTION AT THAT TIME. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN AND ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1142

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR