Products and Procedures
Spinal cord stimulation can be an effective alternative or adjunct treatment to other therapies to manage chronic back and/or leg pain. Medtronic offers a portfolio of spinal cord neurostimulators that deliver targeted chronic pain management. Only the Medtronic Restore® neurostimulators for spinal cord stimulation have FDA-approved labeling for 1.5-Tesla MRI head scans.
Medtronic has been innovating in neurostimulator technology for more than 30 years. In that time, over 250,000 patients have benefited from Medtronic spinal cord stimulation. Medtronic provides clinicians and patients with reliable, best-in-class pain management systems and service.
Our spinal cord stimulation systems include the following components:
Procedural content for spinal cord stimulation includes:
Products for Spinal Cord Stimulation
Neurostimulators
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RestoreSensor NeurostimulatorModel 37714 |
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RestoreUltra NeurostimulatorModel 37712 |
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RestoreAdvanced NeurostimulatorModel 37713 |
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RestorePrime NeurostimulatorModel 37701 |
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PrimeAdvanced NeurostimulatorModel 37702 |
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Itrel 3 NeurostimulatorModel 7425 |
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External Trialing SystemModel 37022 and 355531 |
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Discontinued Products
What does this mean?Synergy NeurostimulatorModel 7427 |
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Synergy Versitrel NeurostimulatorModel 7427V |
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Leads
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16-Electrode Surgical LeadsSpecify™ 2x8 Model 39286 |
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8-Electrode Surgical LeadsSpecify Model 3998 |
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4-Electrode Surgical LeadsResume® II Model 3587A |
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1x8 Percutaneous Leads1x8 Compact Model 3778 |
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1x4 Percutaneous LeadsPisces™ Quad Model 3487A |
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1x8 Test Leads1x8 Standard Model 3873 |
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Extensions
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1x8 ExtensionModel 37081 |
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Stretch-Coil Single ExtensionModel 37083 |
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Stretch-Coil Bifurcated ExtensionModel 37082 |
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Low-Profile Quad ExtensionModel 7489 |
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Programmers
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N'Vision Clinician ProgrammerModel 8840 |
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MyStim Patient ProgrammerModel 37744 |
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Accessories
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Pocket Adaptor Kit1x4 Model 74001 |
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Spinal Cord Stimulation System Procedure Overview
A typical spinal cord stimulation system implant is completed in 2 stages. The first stage is a 3- to 7-day screening test to evaluate whether or not the patient is a candidate for the second stage – the spinal cord stimulation system implant.
Screening Test
During a neurostimulation screening test, the patient receives a temporary, external neurostimulation system for 3 to 7 days. Either percutaneous leads or surgical leads can be used for the screening test.
During the screening test, the patient uses the external neurostimulation trialing system while completing daily activities. In some cases, the patient can use a patient control device to change some stimulation settings within physician-programmed limits.
Throughout the screening test, the external neurostimulator collects patient-use data and the patient records activities, neurostimulation settings, and degree of pain relief in a diary.
After the screening test ends, percutaneous trial lead(s) are removed. Results are evaluated to determine if the patient is a candidate for a spinal cord stimulation system implant.
After the screening test, clinicians review input from the pain management team, the patient, and the patient’s family or caregivers; evaluate if the goals of a neurostimulation trial have been met; and determine if a neurostimulation system will be implanted.
Goals of the screening test:
- Stimulation covers the patient’s pain areas
- Patient is comfortable with the sensation of stimulation
- Patient experiences adequate pain relief
- Patient experiences improved function
Resources
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Percutaneous Lead Implantation Guide
This educational guide presents one representative surgrical procedure from a spinal cord stimulation trial through a system implant, with leads placed using a percutaneous approach.
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Surgical Lead Implantation Guide
This educational guide explains how to implant 16-electrode leads, starting with the spinal cord stimulation trial using percutaneous leads, and continuing through a spinal cord stimulation system implant using surgical leads.
Implant Procedure
Implanting the spinal cord neurostimulation system requires a short surgery, typically done on as an outpatient procedure. The neurostimulator is inserted under the skin through a small incision in the upper buttock. The long-term lead is implanted in the epidural space of the spinal cord.
For detailed information on the spinal cord neurostimulation system implant procedure, refer to the implant manuals for the neurostimulation system products.
Resources
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SCS Procedure Videos
Medtronic offers procedure videos to qualified healthcare professionals. Please register or Log In to view the videos.
Impedance Measurements
Impedance measurements are measurements of the resistance of the lead(s), extension(s), and body tissue that can provide information about the condition of the implanted system (e.g., short circuit, open circuit).
Impedance should be measured during the screening test and implant procedures, and at the beginning and end of each programming session. These measurements verify the integrity of lead/extension/connector pathways. They may provide information about lead problems (e.g., lead breakage, short circuit, open circuit).
Information About Impedance for Spinal Cord Stimulation provides information about:
- Understanding factors that can affect impedance measurements
- Connecting system components properly and checking specific conditions
- Measuring impedance
- Troubleshooting abnormal impedances
Detailed information can also be found in the External Neurostimulator User Manual, the 8840 and 8870 Programmer Guide for Software Version A and the implant manual for each neurostimulator and lead.
Device Replacement
The battery life of the spinal cord neurostimulator will vary depending on the model, stimulation levels, and location of the lead. Clinicians should check the battery level at each follow-up visit.
For a single-incision procedure, the Medtronic pocket adaptor can be used. The pocket adaptor is intended to be implanted with a new replacement 16-electrode neurostimulator in the same pocket used for the explanted neurostimulator.
For detailed information on battery longevity, refer to the System Eligibility and Battery Longevity Specifications Reference Manual.
Procedure Videos
Medtronic offers the following procedure videos to qualified healthcare professionals. Please register or Log In to view these videos.
Neurostimulation Tips and Techniques
This series of videos includes an introduction to basic anatomy of the spinal column, fluoroscopy techniques, and anatomical mapping for pre-implant of a spinal cord stimulation system; and tips and techniques for percutaneous and surgical lead implantation. Within the chapters, surgeons discuss their own experiences.
Introductory Videos
Chapter 1: Basic Anatomy
(8:44, 55 MB)This chapter describes the anatomical structures that are relevant to spinal cord stimulation and its use.
Introductory Videos by Chapter
Chapter 2: Fluoroscopy Techniques
(4:34, 25 MB)Fluorscopy is an imaging modality that uses X-rays to produce images of the spinal column. This chapter describes fluoroscopy techniques used during neurostmulation system implant procedures to verifiy the correct needle placement and visualize the lead as it is implanted.
Chapter 3: Anatomical Mapping
(4:14, 24 MB)This chapter describes the anatomical mapping used for placing two basic types of leads for spinal cord stimulation: percutaneous and surgical.
Procedure Tips and Techniques: Percutaneous Lead Implantation
Chapter 1: Needle Placement
(2:58, 17 MB)This chapter gives tips for the needle placement procedure.
Percutaneous Lead Implantation Video by Chapter
Chapter 2: Lead Placement
(1:54, 11 MB)This chapter provides tips and techniques for placing the lead tip in the targeted area.
Chapter 3: Transverse Tripole
(3:37, 22 MB)This chapter discusses techniques for using a transverse tripole configuration – three-lead arrays – to cover back pain.
Chapter 4: PLI Kit
(3:18, 20 MB)This chapter discusses tips and techniques for using the percutaneous lead introducer (PLI) kit when implanting or replacing percutaneous leads.
Chapter 5: Anchoring Techniques
(3:35, 22 MB)In this chapter, doctors discuss the anchors they prefer and anchoring techniques.
Chapter 7: Staging a Trial Procedure
(3:06, 19 MB)This chapter discusses reasons for implanting a percutaneous lead during a trial assessment.
Procedure Tips and Techniques: Surgical Lead Implantation
Chapter 1: Trial
(1:29, 8 MB)This chapter discusses the use of one or more percutaneous leads during a trial assessment. Percutaneous leads are generally used during the screening test even in cases where a patient may eventually receive a surgical lead implant.
Surgical Lead Implantation Video by Chapter
Chapter 2: Lead Placement
(1:58, 11 MB)In this chapter, the placement of surgical leads is demonstrated.
Chapter 3: Insertion Techniques
(1:56, 10 MB)This chapter demonstrates techniques for inserting the lead into the epidural space and verifying its position.
Chapter 4: Extensions
(1:25, 8 MB)This chapter shows techniques for adding an extension.
Chapter 5: Anchoring
(1:56, 11 MB)In this chapter, doctors share their thoughts about using anchors.
Additional Tips
Chapter 1: Pocket Creation
(3:58, 24 MB)This chapter provides tips for creating a pocket for the neurostimulator and selecting a location for the pocket.
Additional Tips Video by Chapter
Chapter 2: Tunneling
(1:54, 11 MB)This chapter demonstrates the use of the tunneling tool, used when implanting the complete neurostimulation system.
Chapter 3: Connections
(2:28, 14 MB)If extensions are used, they must be connected to the leads. This chapter demonstrates techniques used to connect the extension to the lead, and connecting the extension or lead to the neurostimulator.
Chapter 4: Strain Relief Loops
(2:48, 17 MB)The use of strain relief loops is recommended for lead and neurostimulator implants. This chapter demonstrates the use of strain relief loops during the implant procedure.
Chapter 5: Closing Techniques
(2:19, 13 MB)This chapter demonstrates closing techniques used after the implant procedure.
Physician Interviews
Section 1: Anatomical Mapping
In this group of videos, four physicians discuss various neurostimulation tips and techniques. The physicians interviewed include George T. Mandybur, MD; Ralph Rashbaum, MD; Thomas Strauss, MD; William O. Witt, MD.
In Section 1: Anatomical Mapping, the physicians recommend planning ahead to make sure the stimulation is where the patient requires it. They suggest ways to think about the electrode configuration and map the target areas based on the patient’s pain location.
Do you have any particular tips for a successful anatomical mapping procedure?
Dr. Mandybur
(1:39, 9 MB)Dr. Rashbaum
(6:04, 38 MB)Dr. Stauss
(3:17, 20 MB)Dr. Witt
(2:27, 15 MB)Section 2: Surgical Lead Placement
This video provides tips for optimal lead placement, including using a pain drawing to identify the targets and making sure the needle is at the proper angle when it enters the epidural space. It also describes what to expect if needles are poorly placed or the electrode is off center.
Do you have any tips for ensuring successful surgical lead placement?
Dr. Mandybur
(1:13, 7 MB)Dr. Rashbaum
(1:20, 7 MB)Dr. Stauss
(2:24, 14 MB)Dr. Witt
(2:29, 15 MB)If you don’t follow these procedures or tips, what might you see?
Dr. Mandybur
(1:34, 9 MB)Dr. Rashbaum
(3:09, 19 MB)Dr. Stauss
(1:18, 7 MB)Dr. Witt
(2:00, 12 MB)How would you correct what you see?
Dr. Stauss
(1:26, 8 MB)Dr. Witt
(1:51, 11 MB)What do you think is the value of using a Specify 5-6-5 surgical lead vs. other surgical leads available in the market?
Dr. Mandybur
(1:26, 8 MB)Are there circumstances where you would use leads with different spacing?
Dr. Stauss
(3:36, 22 MB)Are there circumstances where you would choose to implant two leads with different spacing on one patient?
Dr. Stauss
(1:12, 6 MB)Do you have any additional comments regarding placing leads?
Dr. Stauss
(1:44, 10 MB)Section 3: Using a PLI (Percutaneous Lead Introducer) Kit
Topics include how to safely use the percutaneous lead introducer kit for lead exchanges using a single incision regardless of the number of leads.
When do you recommend using a PLI (Percutaneous Lead Introducer) kit?
Dr. Witt
(6:20, 40 MB)Do you have any tips that you can share with others that are learning to use a PLI kit?
Dr. Witt
(4:29, 28 MB)Do you have any additional comments regarding the use of PLI kits?
Dr. Witt
(2:28, 15 MB)Section 4: Trial Assessment Using a Buried Lead
The physicians describe circumstances when they would choose to bury a lead during the trial procedure and provide tips for a successful buried lead trial.
Under what circumstances would you choose to bury a lead during a trial vs. externalize the lead?
Dr. Rashbaum
(1:55, 11 MB)Dr. Stauss
(1:30, 8 MB)Dr. Witt
(5:07, 32 MB)Do you have any special tips or techniques for a successful buried trial? If so, please explain.
Dr. Rashbaum
(3:08, 18 MB)Section 5: Anchoring Techniques
The physicians discuss their choice of anchors (EZ bumpy, Titan, and twist-lock), whether to anchor surgical leads, and the importance of strain relief loops.
Do you choose to anchor surgical leads? Please explain.
Dr. Mandybur
(1:34, 9 MB)When would you use a Titan anchor vs. a twist-lock anchor?
Dr. Witt
(3:35, 22 MB)Why do you like to use EZ (bumpy) anchors with silicone vs. other anchors?
Dr. Stauss
(2:36, 16 MB)Dr. Rashbaum
(3:51, 23 MB)Do you have tips for using the bumpy anchor?
Dr. Stauss
(2:28, 15 MB)Section 6: Single Incision Technique
The physicians describe circumstances when the single incision technique vs. tunneling leads is indicated, and the benefits of single incisions.
Under what circumstances would you choose to use a single incision technique vs. tunneling leads?
Dr. Stauss
(2:44, 16 MB)Dr. Witt
(5:17, 33 MB)Are there any additional techniques you use that have worked well and would be helpful for other implanters?
Dr. Stauss
(1:18, 7 MB)Section 7: Techniques for a Successful Trial
The physicians describe the trialing procedure and offer techniques for a successful trial, including how to prepare patients in advance and explain realistic expectations.
Please explain the trialing procedure for today’s surgical lead implant case.
Dr. Mandybur
(1:21, 7 MB)Do you have any special tips or techniques for a successful trial? If so, please explain.
Dr. Stauss
(3:28, 21 MB)Section 8: Three-lead Implant Technique
The physicians explain the three-lead implant technique to precisely focus stimulation and describe circumstances when transverse tripole is indicated for patients with specific types of pain.
Can you explain your three-lead implant technique?
Dr. Rashbaum
(1:47, 10 MB)Dr. Stauss
(2:33, 15 MB)Dr. Witt
(4:02, 25 MB)Under what circumstances would you choose to implant three leads vs. two?
Dr. Rashbaum
(2:44, 16 MB)Dr. Stauss
(2:10, 13 MB)Do you have any additional tips for a successful transverse tripole implant?
Dr. Stauss
(2:44, 16 MB)Dr. Witt
(1:31, 8 MB)Section 9: Using a Laminotomy or Laminectomy Technique
Dr. Mandybur discusses situations when limited laminotomy or complete laminectomy may be necessary.
Do you prefer to use a laminotomy or laminectomy technique? Please explain why?
Dr. Mandybur
(1:06, 6 MB)How do you decide the level at which you will perform this procedure?
Dr. Mandybur
(1:46, 10 MB)Section 10: Lead Revision
Dr. Mandybur describes how to correct a lead that appears to be off midline. He also discusses removing and replacing a surgical lead and identifies the tools used during the procedure.
Do you have a recommended technique for removing or replacing a surgical lead?
Dr. Mandybur
(1:37, 9 MB)Do you use any special tools when you are doing a surgical lead revision? If so, what are they?
Dr. Mandybur
(1:33, 8 MB)How would you correct a lead that appears to be off midline?
Dr. Mandybur
(1:40, 9 MB)Section 11: Choosing Straight-tip vs. Curved-tip Needles
The physicians discuss their preferences for using one type of needle over the other, and describe the advantages of using a straight-tip needle or a curved-tip needle in certain situations. They also provide tips for successful needle placement.
In what situation would you use one type of needle over the other (straight vs. curved)?
Dr. Stauss
(2:52, 17 MB)Are there certain situations where you would choose to use a straight-tip needle?
Dr. Stauss
(1:16, 7 MB)Why do you like using the curved-tip needle?
Dr. Witt
(3:08, 19 MB)Why do you prefer to use straight-tip needles vs. curved-tip-needles?
Dr. Rashbaum
(4:09, 26 MB)Do you have anything else that you would like to add regarding your choice of needles?
Dr. Rashbaum
(1:17, 7 MB)Do you have any tips for successful needle placement?
Dr. Rashbaum
(5:38, 35 MB)Section 12: Additional Tips
Physicians share techniques for using the passing elevator, including strain relief loops in a surgical implant, and creating pockets.
Do you have any tips for using the passing elevator?
Dr. Mandybur
(1:36, 9 MB)Can you explain the importance of including strain relief loops in a surgical implant?
Dr. Mandybur
(1:10, 6 MB)Please explain your pocket creation technique.
Dr. Rashbaum
(2:49, 17 MB)Manuals and Technical Resources
Prescribing and Pre-implant Manuals
This document includes information about contraindications, adverse events, component disposal, and other information regarding spinal cord stimulation for chronic pain.
This manual includes system eligibility for test stimulation and battery longevity for the RestoreUltra® model 37712, RestoreSensor® model 37714, RestoreAdvanced® model 37713, Restore® model 37711, PrimeAdvanced® model 37702, RestorePrime® model 37701, Synergy® Plus model 7479, Synergy Compact model 7479B, Synergy model 7427, and Synergy Versitrel® model 7427V spinal cord stimulation systems.
The clinical use of Itrel®, PrimeAdvanced, Restore, RestoreAdvanced, RestorePrime, RestoreSensor, RestoreUltra, Synergy, SynergyCompact, SynergyPlus, and Synergy Versitrel Neurostimulation Systems is supported by Medtronic clinical studies of the Mattrix and Itrel 3 spinal cord stimulation (SCS) systems. In addition, the AdaptiveStim® feature of the RestoreSensor neurostimulation system is further supported by the RestoreSensor study.
Screening Test Manuals
The external neurostimulator model 37022 is used to evaluate a Medtronic spinal cord neurostimulator system during lead placement or test stimulation. This manual includes the instructions for use.
This manual provides instructions for using the Multi-Lead Trialing Cable Model 355531 during the spinal cord stimulation screening trial.
This manual includes the instructions for using the 1x8 standard model 3873, compact model 3874, and sub-compact model 3875 test leads for spinal cord stimulation.
Neurostimulator Implant Manuals
This manual provides instructions for implanting the RestoreSensor spinal cord neurostimulator model 37714.
This manual provides instructions for implanting the RestoreAdvanced spinal cord neurostimulator model 37713.
This manual provides instructions for implanting the RestorePrime spinal cord neurostimulator model 37701.
This manual provides instructions for implanting the PrimeAdvanced spinal cord neurostimulator model 37702.
This manual provides instructions for implanting the Itrel 3 spinal cord neurostimulator model 7425.
This manual provides instructions for implanting the Synergy and Synergy Versitrel spinal cord neurostimulator models 7427 and 7427V.
Lead and Extension Implant Manuals
This technical manual provides instructions for using the Specify 2x8 lead kit model 39286 for spinal cord stimulation.
This technical manual provides instructions for using the Specify 5-6-5 lead kit model 39565 for spinal cord stimulation.
This manual provides instructions for using the Specify™ lead kit model 3998 for spinal cord stimulation.
This manual provides instructions for using the 2x4 Hinged Specify lead kit model 3999 for spinal cord stimulation.
This manual provides instructions for using the Resume® II lead kit model 3587A, Resume TL lead kit model 3986A, SymMix® lead kit model 3982A, and On-Point® lead kit model 3987A for spinal cord stimulation.
This manual provides instructions for using the 1x8 percutaneous compact model 3778, standard model 3777, and sub-compact model 3776 lead kits for spinal cord stimulation.
This manual provides instructions for using the 1×4 Pisces Quad® model 3487A, Pisces Quad Compact model 3887, and Pisces Quad Plus model 3888 lead kits for spinal cord stimulation.
This manual provides instructions for using the 1x8 low impedance extension kit model 37081 for spinal cord stimulation.
This manual provides instructions for using the stretch-coil single extension kit model 37083 for spinal cord stimulation.
This manual provides instructions for using the stretch-coil bifurcated extension kit model 37082 for spinal cord stimulation.
This manual provides instructions for using the low-profile quad extension model 7489 for spinal cord stimulation.
Accessory Implant Manuals
This manual provides instructions for using the 1x4 and 2x4 pocket adaptors, model 74001 and 74002, for spinal cord stimulation.
Clinician Programming Manuals
This guide presents technical programming information and usage for the N'Vision® clinician programmer model 8840 for spinal cord stimulation.
This programming guide for software version A (8870) supports the RestoreSensor spinal cord stimulation system and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.
This programming guide for software version A (8870) supports the RestoreUltra spinal cord stimulation system and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.
This programming guide for software version A (8870) supports the RestoreAdvanced and PrimeAdvanced spinal cord stimulation systems and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.
This programming guide for software version A (8870) supports the RestorePrime spinal cord stimulation system and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.
This programming guide for software version A (8870) supports the Itrel 3 spinal cord stimulation system and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.
This programming guide is for programming 4-lead systems using the model 37082 extension for spinal cord stimulation.
Patient Manuals
This is the user manual for the MyStim® patient programmer model 37744 for use in spinal cord stimulation.
This is the user manual for the charging system model 37751 for spinal cord stimulation.
MRI Resources
The considerations in this standard letter guide the appropriate use of magnetic resonance imaging for head-only scans in patients with an implanted spinal cord stimulation system. Included in this letter are references to clinical articles and case studies that address the various issues related to MRI and SCS systems.
Technical Resources
Implant Resources
Pocket Adaptor Kit for Spinal Cord Stimulation: Procedure Tips
This guide provides an overview of procedures for connecting the pocket adaptor to extensions and a spinal cord neurostimulator. It also contains extension and neurostimulator compatibility as well as neurostimulator socket and electrode numbering configurations.
Specify 5-6-5 Technical Design Summary
This summary was designed to provide detail about how and why the Specify 5-6-5 surgical lead was made for spinal cord stimulation.
Percutaneous Lead Implantation Guide
This educational guide presents one representative surgical procedure from a spinal cord stimulation trial through a system implant, with leads placed using a percutaneous approach.
Surgical Lead Implantation Guide
This educational guide explains how to implant 16-electrode leads, starting with the spinal cord stimulation trial using percutaneous leads, continuing through a spinal cord stimulation system implant using surgical leads.
Clinician Programming Resources
RestoreSensor, RestoreUltra, RestoreAdvanced, and PrimeAdvanced Programming Reference Guide
This guide describes many primary attributes of the RestoreSensor, RestoreUltra, RestoreAdvanced, and PrimeAdvanced spinal cord stimulation systems and the N’Vision clinician programmer model 8840. This guide does not replace the product technical manual.
Specify 5-6-5 Programming Instructions Addendum
If the 8870 software application does not display a 3-column 5-6-5 lead electrode configuration on the programmer screen, use these instructions in spinal cord stimulation.
Resources for Patients
MyStim Quick Guide – English
MyStim Quick Guide – Spanish
Programming guides in English and Spanish for MyStim patient programmer models 37742, 37743, and 37744 for patient use with spinal cord stimulation. This guide does not replace the product technical manuals.
TargetMyStim Quick Guide Supplement – English
TargetMyStim Quick Guide Supplement – Spanish
Programming quick guide supplement for using TargetMyStim with the MyStim patient programmer model 37743 for use in spinal cord stimulation. This guide does not replace the product technical manuals.
Recharging System Quick Guide – English
Recharging System Quick Guide – Spanish
Quick reference guide for recharging both the neurostimulator battery and the recharger battery.