BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 302-20

    MDR report key: 817770 · Received February 2, 2007

    Report

    Report Number
    1644487-2007-00012
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    January 1, 2006
    Report Date
    December 5, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    X-RAYS DATED 2006 REVIEWED BY MFR ON 1/31/2007. TWO SUSPECT AREAS WERE VISUALIZED ON THE X-RAYS REVIEWED, ONE PROXIMAL TO THE ANCHOR TETHER AND ONE 1.9CM DISTAL TO THE NEGATIVE ELECTRODE. THE SUSPECT AREAS WERE ON THE PORTION OF THE LEAD NOT RETURNED TO CYBERONICS, INC. NO LEAD BREAK WAS IDENTIFIED DURING PRODUCT ANALYSIS ON THE PORTION OF THE LEAD RETURNED TO CYBERONICS, INC. CONCLUSION: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A SYSTEM DIAGNOSTICS TEST AT THE OFFICE RESULTED IN HIGH LEAD IMPEDANCE INDICATING A POSSIBLE LEAD BREAK. PT REPORTED NOT FEELING STIMULATION AT THE TIME OF THIS OFFICE VISIT. NO REPORT OF PT TRAUMA OR INJURY WAS REC'D FROM THE SITE IN RELATION TO THE REPORT OF HIGH LEAD IMPEDANCE. DURING REVISION SURGERY IN 2006 TO REPLACE THE LEAD, NO OBVIOUS EXPLANATIONS FOR THE HIGH IMPEDANCE WERE IDENTIFIED BY THE SURGEON. THE LEAD ASSEMBLY, MINUS THE ELECTRODES WAS RETURNED. NO DISCONTINUITIES WERE IDENTIFIED DURING THE VISUAL AND ELECTRICAL ANALYSIS OF THE RETURNED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 302-20 LYJ LYJ CYBERONICS, INC. 302-20 1598

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR