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Spinal Cord Stimulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • SCS Product Family - RestoreSensor, MyStim, NVision

    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 spinal cord stimulation systems give patients long-lasting relief from chronic pain and access to advanced diagnostic care.

    Only Medtronic offers a pain neurostimulation system for safe* access to MRI scans anywhere on the body. With Medtronic SureScan® MRI Technology, pain stimulation patients have safe access to an MRI scan whenever the need arises.

    Our spinal cord stimulation systems include the following components:

    Procedural content for spinal cord stimulation includes:

    *Under specific conditions. Requires SureScan MRI implantable neurostimulator and SureScan MRI lead/s. Refer to MRI Guidelines for full list of conditions.

    Products for Spinal Cord Stimulation

    Neurostimulators

    RestoreSensor SureScan MRI Neurostimulator View larger

    RestoreSensor SureScan MRI Neurostimulator

    Model 97714

    Product Details
    RestoreSensor Neurostimulator View larger

    RestoreSensor Neurostimulator

    Model 37714

    Product Details
    RestoreUltra SureScan MRI Neurostimulator 97712 View larger

    RestoreUltra SureScan MRI Neurostimulator

    Model 97712

    Product Details
    97713-restore-adv-th View larger

    RestoreAdvanced SureScan MRI Neurostimulator

    Model 97713

    Product Details
    PrimeAdvanced SureScan MRI Neurostimulator View larger

    PrimeAdvanced SureScan MRI Neurostimulator

    Model 97702

    Product Details
    Itrel 4 Neurostimulator View larger

    Itrel 4 Neurostimulator

    Models 37703 and 37704

    Product Details
    External Neurostimulator Trialing System View larger

    External Trialing System

    Model 37022 and 355531

    Product Details

    Leads

    vectris-lead-th View larger

    1x8 Vectris SureScan MRI Percutaneous Leads

    Subcompact Model 977A1
    Compact Model 977A2

    Product Details
    1x8 Percutaneous Leads for Spinal Cord Stimulation View larger

    1x8 Percutaneous Leads

    1x8 Compact Model 3778
    1x8 Standard Model 3777
    1x8 Sub-Compact Model 3776

    Product Details
    1x4 Percutaneous Leads for Spinal Cord Stimulation View larger

    1x4 Percutaneous Leads

    Pisces™ Quad Model 3487A
    Pisces Quad Compact Model 3887
    Pisces Quad Plus Model 3888

    Product Details
    8-Electrode Surgical Leads for Spinal Cord Stimulation View larger

    8-Electrode Surgical Leads

    Specify Model 3998
    Specify 2x4 Hinged  Model 3999

    Product Details
    16-Electrode Surgical Leads View larger

    16-Electrode Surgical Leads

    Specify™ 2x8 Model 39286
    Specify 5-6-5 Model 39565

    Product Details
    vectris-trial-lead-th View larger

    Vectris Trial Leads

    1x8 Subcompact Model 977D160
    1x8 Compact Model 977D260

    Product Details
    1x4 Percutaneous Leads for Spinal Cord Stimulation View larger

    1x8 Test Leads

    1x8 Standard Model 3873
    1x8 Compact Model 3874
    1x8 Sub-Compact Model 3875

    Product Details

    Extensions

    1x8 Extension Model 37081 for Spinal Cord Stimulation View larger

    1x8 Extension

    Model 37081

    Product Details
    Stretch-Coil Single Extension Model 37083 for Spinal Cord Stimulation View larger

    Stretch-Coil Single Extension

    Model 37083

    Product Details
    Stretch-Coil Bifurcated Extension Model 37082 for Spinal Cord Stimulation View larger

    Stretch-Coil Bifurcated Extension

    Model 37082

    Product Details
    7489 Quad Extension View larger

    Low-Profile Quad Extension

    Model 7489

    Product Details

    Programmers

    N’Vision Clinician Programmer Model 8840 for Spinal Cord Stimulation View larger

    N'Vision Clinician Programmer

    Model 8840

    Product Details
    MyStim 97740 Patient Programmer View larger

    MyStim Patient Programmer

    Model 97740

    • POWER SOURCE : 2 AAA alkaline batteries (LR03)
    • BATTERY LIFE : 2 months (average)
    • SIZE : 9.4 x 5.6 x 2.8 cm (3.7 x 2.2 x 1.1 in)
    • WEIGHT : 111 g (3.9 oz)
    • Patient Programmer User Manual
    Product Details

    Accessories

    Pocket Adaptor Kit for Spinal Cord Stimulation View larger

    Pocket Adaptor Kit

    1x4 Model 74001
    2x4 Model 74002

    • RESISTANCE : Maximum 50.0 Ω
    • LENGTH : 25.5 cm (Model 74001), 27.4 cm (Model 74002)
    • DISTAL END CONNECTOR PORTS : Quadripolar
    • PROXIMAL END CONNECTOR : Octapolar, in-line
    • Pocket Adaptor Kit Implant Manual
    Product Details
    injex-sm View larger

    Injex Anchoring System

    Models 97791 and 97792

    Product Details

    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 trial to evaluate whether or not the patient is a candidate for the second stage – the spinal cord stimulation system implant.

    Screening Trial

    During a neurostimulation screening trial, the patient receives a temporary, external neurostimulation system for 3 to 7 days. Percutaneous leads are used for the screening trial.

    During the screening trial, 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 trial, 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 trial 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 trial, 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 trial:

    • Stimulation covers the patient’s pain areas
    • Patient is comfortable with the sensation
    • Patient experiences adequate pain relief
    • Patient experiences improved function

    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 buttock, abdomen, or flank. 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.

    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).

    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.

    Manuals and Technical Resources

    Prescribing and Pre-implant Manuals

    Medtronic Spinal Cord Stimulation Information for Prescribers

    This document includes information about contraindications, adverse events, component disposal, and other information regarding spinal cord stimulation for chronic pain.

    Spinal Cord Stimulation - Indications Insert

    This insert presents the indications for Medtronic spinal cord stimulation for chronic pain.

    System Eligibility and Battery Longevity Specifications Reference Manual

    This manual provides information on test stimulation, screening for patient eligibility, battery charging frequency, and battery longevity of Medtronic spinal cord stimulation systems.

    Clinical Summary for Advanced Pain Therapy Using Neurostimulation for Chronic Pain

    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

    External Neurostimulator Technical Manual

    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.

    Multi-Lead Trialing Cable Technical Manual

    This manual provides instructions for using the Multi-Lead Trialing Cable Model 355531 during the spinal cord stimulation screening trial.

    Vectris 1x8 Trial Screening Lead Kit Implant Manual

    This technical manual includes the instructions for implanting the Vectris 1x8 sub-compact and 1x8 compact trial leads for evaluating spinal cord stimulation.

    1x8 Test Stimulation Lead Kits Implant Manual

    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

    RestoreSensor SureScan MRI 97714 Neurostimulator Implant Manual

    This manual provides instructions for implanting the RestoreSensor® SureScan® MRI spinal cord neurostimulator model 97714.

    RestoreSensor Neurostimulator Implant Manual

    This manual provides instructions for implanting the RestoreSensor spinal cord neurostimulator model 37714.

    RestoreUltra SureScan MRI 97712 Neurostimulator Implant Manual

    This manual provides instructions for implanting the RestoreUltra® SureScan® MRI spinal cord neurostimulator model 97712.

    RestoreUltra Neurostimulator Implant Manual

    This manual provides instructions for implanting the RestoreUltra® spinal cord neurostimulator model 37712.

    RestoreAdvanced SureScan MRI 97713 Neurostimulator Implant Manual

    This manual provides instructions for implanting the RestoreAdvanced® SureScan MRI spinal cord neurostimulator model 97713.

    RestoreAdvanced Neurostimulator Implant Manual

    This manual provides instructions for implanting the RestoreAdvanced spinal cord neurostimulator model 37713.

    RestorePrime Neurostimulator Implant Manual

    This manual provides instructions for implanting the RestorePrime® spinal cord neurostimulator model 37701.

    PrimeAdvanced Neurostimulator Implant Manual

    This manual provides instructions for implanting the PrimeAdvanced® spinal cord neurostimulator model 37702.

    PrimeAdvanced SureScan MRI 97702 Neurostimulator Implant Manual

    This manual provides instructions for implanting the PrimeAdvanced SureScan MRI spinal cord neurostimulator model 97702.

    Itrel 4 Neurostimulator Model 37703 Implant Manual

    This manual provides instructions for implanting the Itrel® 4 spinal cord neurostimulator model 37703.

    Itrel 4 Neurostimulator Model 37704 Implant Manual

    This manual provides instructions for implanting the Itrel 4 spinal cord neurostimulator model 37704.

    Itrel 3 Neurostimulator Implant Manual

    This manual provides instructions for implanting the Itrel 3 spinal cord neurostimulator model 7425.

    Synergy Model 7427 and Synergy Versitrel Model 7427V Technical Manual

    This manual provides instructions for implanting the Synergy® and Synergy Versitrel® spinal cord neurostimulator models 7427 and 7427V.

    Lead and Extension Implant Manuals

    Vectris SureScan MRI 1x8 Lead Kit Implant Manual

    This technical manual provides instructions for using the Vectris® 1x8 subcompact lead kit model 977A1 and 1x8 compact lead kit model 977A2 for spinal cord stimulation.

    Specify 2x8 Lead Kit Implant Manual

    This technical manual provides instructions for using the Specify 2x8 lead kit model 39286 for spinal cord stimulation.

    Specify 5-6-5 Lead Kit Implant Manual

    This technical manual provides instructions for using the Specify 5-6-5 lead kit model 39565 for spinal cord stimulation.

    Specify Lead Kit Model 3998 Implant Manual

    This manual provides instructions for using the Specify™ lead kit model 3998 for spinal cord stimulation.

    2x4 Hinged Specify Lead Implant Manual

    This manual provides instructions for using the 2x4 Hinged Specify lead kit model 3999 for spinal cord stimulation.

    Resume II, Resume TL, Symmix, On-Point Lead Kit Implant Manual

    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.

    1x8 Standard, Compact and Sub-Compact Leads Implant Manual

    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.

    1×4 Pisces Quad Leads Implant Manual

    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.

    1x8 Low Impedance Extension Implant Manual

    This manual provides instructions for using the 1x8 low impedance extension kit model 37081 for spinal cord stimulation.

    Stretch-Coil Single Extension Implant Manual

    This manual provides instructions for using the stretch-coil single extension kit model 37083 for spinal cord stimulation.

    Stretch-Coil Bifurcated Extension Implant Manual

    This manual provides instructions for using the stretch-coil bifurcated extension kit model 37082 for spinal cord stimulation.

    Low-Profile Quad Extension Implant Manual

    This manual provides instructions for using the low-profile quad extension model 7489 for spinal cord stimulation.

    Accessory Implant Manuals

    Injex Model 97791 Instructions for Use

    This document includes instructions for using the Injex anchoring system model 97791 (bumpy).

    Injex Model 97792 Instructions for Use

    This document includes instructions for using the Injex anchoring system model 97792 (bi-wing).

    Pocket Adaptor Kit Implant Manual

    This manual provides instructions for using the 1x4 and 2x4 pocket adaptors, model 74001 and 74002, for spinal cord stimulation.

    Clinician Programming Manuals

    N’Vision Clinician Programmer Technical Manual

    This guide presents technical programming information and usage for the N'Vision® clinician programmer model 8840 for spinal cord stimulation.

    RestoreSensor Software Programming Guide

    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.

    RestoreSensor SureScan MRI Software Programming Guide

    This programming guide supports the RestoreSensor SureScan MRI 97714 spinal cord stimulation system and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.

    RestoreUltra Software Programming Guide

    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.

    RestoreUltra SureScan MRI Software Programming Guide

    This programming guide supports the RestoreUltra SureScan MRI 97712 spinal cord stimulation system and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.

    RestoreAdvanced SureScan MRI and PrimeAdvanced SureScan MRI Software Programming Guide

    This programming guide supports the RestoreAdvanced SureScan MRI and PrimeAdvanced SureScan MRI spinal cord stimulation systems and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.

    RestoreAdvanced and PrimeAdvanced Software Programming Guide

    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.

    RestorePrime Software Programming Guide

    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.

    Itrel 4 Software Programming Guide

    This programming guide for software version A (8870) supports the Itrel 4 spinal cord stimulation system and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.

    Synergy, Synergy Versitrel, Itrel 3, and Itrel II Software Programming Guide

    This programming guide for software version A (8870) supports the Synergy, Synergy Versitrel, Itrel 3 and Itrel II neurostimulation systems and the N'Vision clinician programmer. The guide supplements information provided in the neurostimulator technical manual.

    Programming Four-Lead Systems

    This programming guide is for programming 4-lead systems using the model 37082 extension for spinal cord stimulation.

    Patient Manuals

    MyStim Patient Programmer User Manual

    This is the patient manual for the MyStim® patient programmer model 97740 for use with neurostimulation system models 97714, 97713, 97712, 97702, 37701, 37702, 37703, 37704, 37711, 37712, 37713, 37714, and 37022.

    Recharger Charging System Patient User Manual

    This is the user manual for the charging system model 37751 for spinal cord stimulation.

    MRI Guidelines

    MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain - Instructions for Use

    This manual includes warnings, precautions, and patient eligibility information associated with the use of MRI scans in patients with in implanted spinal cord stimulation system.

    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.

    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. Most of the information in this guide pertains to both the SureScan MRI and earlier non-SureScan neurostimulation systems.

    Itrel 4 Programming Reference Guide

    This guide describes many primary attributes of the Itrel 4 spinal cord stimulation systems and the N’Vision clinician programmer model 8840. This guide does not replace the product technical manual.

    Resources for Patients

    MyStim Quick Guide (for RestoreSensor)

    Programming guide for MyStim® patient programmer model 97740 for patient use with the RestoreSensor neurostimulator. This guide does not replace the product manuals.

    MyStim Quick Guide (for Neurostimulators Other Than RestoreSensor and Itrel 4)

    Programming guide for MyStim patient programmer models 37742, 37743, 37744, and 97740 for patient use with all neurostimulators except RestoreSensor and Itrel 4. This guide does not replace the product manuals.

    MyStim Quick Guide for Itrel 4

    This programming quick guide is for MyStim patient programmer model 37746 for patient use with the Itrel 4 neurostimulator. This guide does not replace the product manuals.

    Recharging System Quick Guide – English
    Recharging System Quick Guide – Spanish

    Quick reference guide for recharging both the neurostimulator battery and the recharger battery.

     

     

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