BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3923806 · Received July 9, 2014

    Report

    Report Number
    1644487-2014-01742
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT SURGERY HIGH IMPEDANCE WAS FOUND WITH THE EXISTING LEAD AND GENERATOR. THE SURGEON REPLACED THE GENERATOR AND HIGH IMPEDANCE WAS AGAIN OBSERVED WITH THE NEW GENERATOR AND EXISTING LEAD. THE SURGEON THEN REPLACED THE LEAD. IT WAS REPORTED THAT DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS WITH THE NEW VNS SYSTEM. IT WAS REPORTED THAT THE HIGH IMPEDANCE WAS NOT OBSERVED PRIOR TO SURGERY. IT WAS REPORTED THAT THE EXPLANTING FACILITY DOES NOT RETURNED EXPLANTED DEVICES FOR ANALYSIS AND THAT THE DEVICES WERE DISCARDED DURING THE SURGERY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPLANTING HAS A NO RETURN POLICY AND DISCARDS EXPLANTED DEVICES AT THE TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401588 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-30 200104

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR