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MR-conditionality failure modes: a comparison across various spinal cord stimulators.

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Summary

Spinal cord stimulation (SCS) devices require magnetic resonance imaging (MRI)-conditional labeling for safe chronic pain management. This review details SCS device MRI-conditional status, considering common complications like lead migration.

Keywords:
MR-conditionalitybattery IPG detachmentbreakagefracturelead migrationspinal cord stimulator (SCS)

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Area of Science:

  • Biomedical Engineering
  • Medical Devices
  • Pain Management

Background:

  • Spinal cord stimulation (SCS) is a key therapy for chronic pain management.
  • Magnetic resonance imaging (MRI)-conditional labeling is crucial for SCS device selection.
  • Device complications, such as lead migration, can impact MRI-conditional safety.

Purpose of the Study:

  • To compile and analyze the MRI-conditional specifications of current SCS devices.
  • To evaluate how common SCS device failures affect MRI-conditional status.
  • To provide a comprehensive reference for clinicians and patients regarding SCS device safety during MRI.

Main Methods:

  • Systematic literature review of studies published between 2015 and 2024 in PubMed and Google Scholar.
  • Analysis of US FDA labels for MRI compatibility.
  • Extraction of technical data from SCS device manufacturers and local representatives.

Main Results:

  • MRI-conditional status varies among SCS devices.
  • Lead migration, lead fracture, and battery detachment can compromise MRI-conditional safety.
  • Specific conditions and limitations for MRI use are detailed for each device.

Conclusions:

  • Understanding SCS device MRI-conditional limitations is vital for patient safety.
  • This review offers a consolidated resource on SCS device MRI compatibility under normal and failure conditions.
  • Further research may be needed to standardize MRI-conditional testing and reporting for SCS devices.