BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1569663 · Received December 2, 2009

    Report

    Report Number
    1644487-2009-02684
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 5, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS - X-RAYS REVIEWED BY MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. IN THE AP CHEST VIEW, NEAR THE GENERATOR HEADER AN ACUTE ANGLE IN THE LEAD BODY WAS OBSERVED ONLY BASED ON THAT ONE VIEW. CONCLUSIONS - DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED TO OUR EUROPE OFFICE THAT THEY HAD A PT THAT DID NOT FEEL HIS MAGNET ACTIVATIONS AND UPON INTERROGATION HAD HIGH LEAD IMPEDANCE ON THEIR SYSTEMS AND NORMAL MODE TESTING ERI NO. X-RAYS WERE RECEIVED FOR REVIEW. BASED ON THE X-RAYS REVIEWED, THERE ARE NO OBVIOUS ANOMALIES THAT COULD BE CONTRIBUTING TO THE SYSTEM DIAGNOSTIC RESULT OF DCDC=7 LIMIT HIGH. HOWEVER, IN THE AP CHEST VIEW AN ACUTE ANGLE WAS OBSERVED IN THE LEAD BODY NEAR THE GENERATOR HEADER. IT CANNOT BE DETERMINED IF THIS ACUTE ANGLE IS CONTRIBUTING TO THE DCDC=7 LIMIT HIGH. A LEAD DISCONTINUITY CANNOT BE RULED OUT. NO OTHER OBVIOUS ANOMALIES WERE OBSERVED IN THE PORTIONS OF THE LEAD VISUALIZED THAT COULD BE CONTRIBUTING TO THE REPORTED DCDC=7 LIMIT HIGH RESULT. THE PT DID NOT HAVE ANY FALL OR INJURY PRECEDING THE HIGH IMPEDANCE BEING DISCOVERED. AT THIS TIME UNK IF ANY INTERVENTIONS ARE PLANNED AND IF THE VNS IS PROGRAMMED ON OR OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1732

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR