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Related Experiment Videos

Epidural lead fracture caused by material processing fault.

D Velimirovic1, V Radmilovic, M Djordjevic

  • 1Institute for Cardiovascular Diseases, University Clinical Center, Belgrade, Yugoslavia.

Pacing and Clinical Electrophysiology : PACE
|September 1, 1991
PubMed
Summary

Epidural lead fractures occurred in half of patients receiving the Itrel pacing system for peripheral vascular disease. Material defects during fabrication likely caused these fractures, leading to system dysfunction.

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Area of Science:

  • Biomedical Engineering
  • Materials Science

Background:

  • Implanted Itrel pacing systems are used for peripheral vascular disease.
  • Epidural lead fracture is a potential complication of spinal cord stimulation systems.

Purpose of the Study:

  • To investigate the cause of epidural lead fractures in patients with the Itrel pacing system.
  • To determine the failure mechanism of the Pisces Quad 3487 epidural lead.

Main Methods:

  • Analysis of eight patients with implanted Itrel pacing systems.
  • X-ray fluoroscopy and microscopic examination of fractured epidural leads.
  • Scanning electron microscopy of lead cross-sections.

Main Results:

  • Four out of eight patients experienced epidural lead fracture.

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  • Fractures were confirmed microscopically, with tissue fluid and thrombus present.
  • Scanning electron microscopy revealed microcracks initiated from surface inclusions, propagating via fatigue.

    • Conclusions:

    • The high incidence of epidural lead fracture suggests a link to material fabrication defects.
    • Epidural lead fracture is a significant cause of spinal electrical stimulation pacing system dysfunction.