BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPOLAR LEAD

    MDR report key: 851125 · Received May 14, 2007

    Report

    Report Number
    1644487-2007-00619
    Event Type
    Other
    Date Received
    May 14, 2007
    Date of Event
    November 1, 2004
    Report Date
    September 13, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANOMALIES WERE IDENTIFIED WITH RETURNED PORTION OF THE LEAD WHICH MAY HAVE CONTRIBUTED TO THE REPORTED HIGH LEAD IMPEDANCE. SUSPECTED USER ERROR CAUSED EVENT.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT DUE TO LEAD DISCONTINUITY. FOLLOW-UP WITH THE RE-IMPLANTING SURGEON REVEALED THAT NO LEAD BREAK HAD OCCURRED, BUT RATHER THE "LEAD HAD PULLED OFF THE NERVE AND WAS FURTHER DOWN THE CAROTID SHEATH." PRODUCT WAS RETURNED TO MANUFACTURER AND AN "ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTION AND THE REPORTED LEAD DISCONTINUITY CONDITION WAS NOT VERIFIED. NOTE THAT THE ELECTRODE SECTION WAS NOT RETURNED FOR ANALYSIS AND THEREFORE, A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT." A REVIEW OF THE OPERATIVE NOTES FROM THE ORIGINAL IMPLANT PROCEDURE INDICATES THAT ONLY ONE SYSTEM DIAGNOSTIC TEST WAS PERFORMED, AND THIS TEST WAS PERFORMED PRIOR TO ANCHORING THE ELECTRODES. ALL SUBSEQUENT DIAGNOSTIC TEST RESULTS IN THE PROGRAMMING HISTORY DATABASE INDICATE HIGH LEAD IMPEDANCE. USER ERROR IS SUSPECTED BECAUSE THE ORIGINAL OPERATIVE NOTES DO NOT MENTION THAT A STRAIN RELIEF BEND OR LOOP WAS CREATED PER CYBERONICS LABELING. ALSO, IT WAS NOTED THAT THE PREVIOUS IMPLANTED LEAD WAS 302-30. DURING THE REVISION SURGERY, THE SURGEON ELECTED TO IMPLANT THE SMALLER LEAD, 302-20. SINCE REPLACEMENT SURGERY "THE PATIENT HAS BEEN ABLE TO FEEL STIMULATION...BEFORE THE SURGERY THE PATIENT COULD NOT FEEL STIMULATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD LYJ CYBERONICS, INC. 302-30 010024

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| O| R