BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4223573 · Received November 4, 2014

    Report

    Report Number
    1644487-2014-02915
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. 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 THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE (IMPEDANCE VALUE > 9000 OHMS). X-RAYS WERE TAKEN AND WERE REPORTED BY THE PHYSICIAN TO BE UNREMARKABLE. X-RAYS WERE PROVIDED TO THE MANUFACTURER WHERE REVIEW OF THE IMAGES IS CURRENTLY UNDERWAY. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. X-RAYS DATED (B)(6) 2014 WERE PROVIDED TO THE MANUFACTURER FOR FURTHER REVIEW. THE GENERATOR APPEARS IN THE LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEAR TO BE INTACT. WITH THE IMAGES PROVIDED, THE LEAD CONNECTOR PIN CANNOT BE CONFIRMED TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. PART OF THE LEAD WAS BEHIND THE GENERATOR AND COULD NOT BE ASSESSED. NO CLEAR LEAD BREAKS OR SHARP ANGLES WERE FOUND IN THE PARTS OF THE LEAD THAT COULD BE ASSESSED. BASED ON THE IMAGES PROVIDED, THE CAUSE OF THE HIGH LEAD IMPEDANCE REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707437 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 009946

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR