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Instrumentation problems with implanted neuroaugmentive devices.

C Smith

    Applied Neurophysiology
    |January 1, 1977
    PubMed
    Summary
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    Technical issues with neurostimulation systems implanted between 1971-1977, particularly lead failures, necessitated surgical revisions. Device material and design improvements are crucial for future neuroaugmentive technologies.

    Area of Science:

    • Neurosurgery
    • Biomedical Engineering
    • Materials Science

    Background:

    • Neurostimulation systems were increasingly implanted for therapeutic purposes between 1971 and 1977.
    • Early neuroaugmentive devices faced technical challenges impacting patient outcomes.
    • A significant number of systems required surgical intervention due to device malfunction.

    Purpose of the Study:

    • To analyze the technical problems and failure modes of early neurostimulation systems.
    • To identify the most common causes of system malfunction requiring surgical revision.
    • To provide data supporting the need for improved device design and materials.

    Main Methods:

    • Review of technical issues from 218 neurostimulation system implantations.
    • Categorization of failure types, including transmitter, antenna, and lead components.

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  • Analysis of failure incidence in relation to device age.
  • Main Results:

    • Multiple transmitter and antenna failures were documented.
    • The primary cause of surgical revision involved failures in internal lead conductors and/or insulation.
    • Lead wire failure incidence correlated with the age of the implanted devices.

    Conclusions:

    • Early neurostimulation systems exhibited significant technical vulnerabilities, particularly concerning lead integrity.
    • Device failures frequently necessitated invasive surgical revisions.
    • Substantial advancements in materials and design are imperative for the reliability and efficacy of future neuroaugmentive technologies.