BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 4192656 · Received October 22, 2014

    Report

    Report Number
    1644487-2014-02776
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 29, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 SYSTEM DIAGNOSTICS REVEALED HIGH IMPEDANCE (DC DC ¿ 6). SYSTEM DIAGNOSTICS WERE ALSO PERFORMED DURING AN OFFICE VISIT ON (B)(6) 2014 WITH THE SAME RESULTS. 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. THE LEAD CONNECTOR PIN APPEARS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. 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; HOWEVER, THERE WAS A SUSPECT AREA IN THE LEAD BODY IN THE CHEST SUPERIOR TO THE GENERATOR WHERE COMPLETE LEAD CONTINUITY COULD NOT BE ASSESSED. BASED ON THE IMAGES PROVIDED, THE CAUSE OF THE HIGH LEAD IMPEDANCE REMAINS UNKNOWN. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671417 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 ED-1217

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR