BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 700347 · Received April 12, 2006

    Report

    Report Number
    1644487-2006-00183
    Event Type
    Malfunction
    Date Received
    April 12, 2006
    Report Date
    March 13, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE MANUFACTURER BECAME AWARE OF A PUBLISHED CLINICAL ARTICLE DISCUSSING LEAD BREAKS IN TWO PEDIATRIC PATIENTS. THE ARTICLE, ENTITLED "COMPLICATIONS OF VAGAL NERVE STIMULATION FOR APILEPSY IN CHILDREN" (REF NEUROSURG REV DOI 10. 1007/S10143-005-0005-5), INDICATED THAT 2 OF 36 PTS STUDIED UNDERWENT REPLACEMENT SURGERY MORE THAN THREE YEARS POST IMPLANT DUE TO LEAD FRACTURE. IN BOTH CASES, DEVICE MALFUNCTION WAS SUSPECTED AS A RESULT OF HIGH LEAD IMPEDANCE TEST RESULTS DURING DEVICE DIAGNOSTIC TESTING AND WAS CONFIRMED VIA X-RAY. THE LEAD DISCONTINUITIES IN EACH CASE CAUSED THE HIGH LEAD IMPEDANCE EVENTS, HOWEVER, THE CAUSE OF THE LEAD FRACTURES IS UNKNOWN. NO SERIOUS INJURY WAS REPORTED IN CONJUNCTION WITH EITHER OF THE LEAD BREAKS. NEITHER PT HAD EXPERIENCED ANY RECENT INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE VNS THERAPY SYSTEM. BOTH THE LEAD (INCLUDING ELECTRODES) AND GENERATOR WERE REPLACED IN EACH CASE. REPORT IS COMPLETE BECAUSE ARTICLE AUTHOR REFUSED TO RESPOND TO MANUFACTURER'S REQUEST FOR ADDITIONAL INFORMATION, INDICATING THAT THE INTENT OF THE ARTICLE WAS NOT TO INITIATE A COMPLAINT AGAINST THE VNS THERAPY SYSTEM AND CITING PT PRIVACY LAWS. CONSEQUENTLY, THE RETURN OF THE EXPLANTED DEVICES FOR ANALYSIS IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI LYJ - LEAD LYJ CYBERONICS, INC. 300 OR 302 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO