rsRolesWithAccess exists
AccessRole: []
InDevEnvironment=[false]
IsSectionSecure=[true]
Authorized=[false]
LMSAccess=[false]
HasNeuroHCP=[false]
UserLoggedIn=[false]
Loading

Sacral Neuromodulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • SNS Product Family

    Products and Procedures

    Medtronic Sacral Neuromodulation is a therapy delivered exclusively by the InterStim® System. The implantable neurostimulation system uses a neurostimulator and lead to send electrical pulses to an area near the sacral nerve to help normalize neural activity from the bladder or bowel to the brain. The stimulation parameters are controlled by external, handheld clinician and patient programmers.

    Our InterStim Systems include the following components:

    Procedural content for Sacral Neuromodulation includes:

    Products for Sacral Neuromodulation

    Neurostimulators

    InterStim II Sacral Neurostimulator View larger

    InterStim II Neurostimulator

    Model 3058

    Product Details
    InterStim Sacral Neurostimulator View larger

    InterStim Neurostimulator

    Model 3023

    Product Details

    Leads

    InterStim Therapy Tined Lead in InterStim II Header View larger

    Tined Leads

    Model 3889 and Model 3093

    • LENGTH : 20 to 60 cm (8 to 24 in)
    • SHAPE : Straight
    • DIAMETER : 1.27 mm (0.05 in)
    • ELECTRODE SPACING (3889) : 3 mm (0.12 in)
    • ELECTRODE SPACING (3093) : 1.5 mm (0.06 in)
    • Tined Leads Implant Manual
    Product Details

    Extensions

    InterStim Therapy Quadripolar Extension Model 3095 View larger

    Quadripolar Extension

    Model 3095

    • CONNECTION : Tined lead to neurostimulator model 3023
    • LENGTHS : 10, 25, and 51 cm
    • DISTAL CONNECTOR : Quadripolar
    • PROXIMAL CONNECTOR : Quadripolar
    • Quadripolar Extension Implant Manual
    Product Details

    Programmers

    Medtronic N’Vision Clinician Programmer Model 8840 View larger

    N'Vision Clinician Programmer

    Model 8840

    Product Details
    InterStim iCon Patient Programmer Model 3037 View larger

    InterStim iCon Patient Programmer

    Model 3037

    Product Details

    Procedure Overview

    Evaluation Procedure

    The evaluation allows patients to try the therapy and assess not only its efficacy but also its tolerability and sensation so that they and their physician can make an educated decision whether or not to proceed with an InterStim® System implant. In general, the evaluation is considered a success if the patient experiences a significant reduction in his or her bladder control or bowel control symptoms.

    There are two types of evaluation for Sacral Neuromodulation, delivered by the InterStim System: the basic evaluation and the advanced evaluation. Either one can be used to test Sacral Neuromodulation for Bladder Control or Bowel Control. In both evaluations, a portable, external stimulator generates the stimulation which is delivered via a lead; the patient wears this stimulator throughout the evaluation. Patients complete a symptom diary prior to the evaluation to establish a baseline measure of incontinence; and during the evaluation to measure improvement.

    The basic evaluation (also referred to as Peripheral Nerve Evaluation or PNE) is initiated through a simple, in-office procedure. The advanced evaluation (also referred to as Stage 1) is initiated through an outpatient procedure performed in a hospital or surgical center. Both evaluations are short-term, and the effects are reversible by removing the leads or turning off the device.

    Choose the evaluation option that's best for the individual patient. Here's how the evaluation options compare:

      Basic Evaluation Advanced Evaluation
    Therapy Path

    • Available as an initial evaluation option
    • With positive results, proceed directly to long-term therapy
    • With inconclusive results, the advanced evaluation is recommended

    • Available as an initial evaluation option
    • With positive results, proceed directly to long-term therapy
    • With inconclusive results, consider other therapy options

    Evaluation period • Up to 7 days • Up to 14 days
    Procedure • Performed in office • Performed in hospital outpatient or surgical center
    Anesthetic • Local anesthesia • Monitored anesthesia care or general anesthesia
    Type of lead

    • Flexible, thin wire
    • Easily removed after evaluation
    • One electrode contact

    • Flexible lead with tines that anchor into place
    • Remains in place for long-term therapy after a positive evaluation
    • Four electrode contacts provide more programming options

    Fluoroscopy • May or may not be used • Always used

    When choosing an evaluation option, the clinical assessment of the patient may include:

    • Frequency of incontinence episodes (e.g., typical number of episodes per week)
    • Patient's comfort level with surgery and the therapy
    • Patient size and activity level (tines on the chronic implant lead minimize lead migration in patients who are overweight or active)

    Local carrier or payer policies may also influence the choice of evaluation.

    Complications can occur with the evaluation including implant site pain, movement of the wire, technical problems with the device, and some temporary pain.

    For more information on the evaluation procedure, refer to the Test Stimulation Lead/Kit Technical Manual or InterStim Tined Leads Implant Manual.

    Implant Procedure

    The InterStim System is implanted only if the physician and the patient have identified a successful reduction in the patient's bladder control or bowel control symptoms as a result of the evaluation.

    Implanting the system requires a short surgery, typically done as an outpatient procedure. The sacral nerve neurostimulator is inserted under the skin through a small incision in the upper buttock. The long-term lead is implanted under the skin, with one end of the lead connecting to the neurostimulator. The other end of the lead is placed in the sacral foramen adjacent to a sacral nerve. The electrical stimulation, generated by the neurostimulator and delivered by the lead, modulates nerve activity. 

    In addition to risks related to a surgical procedure such as infection and swelling, neurostimulator or lead related problems may occur and require surgery or cause return of symptoms. For a list of adverse events that have been associated with the therapy, please refer to Indications, Safety, and Warnings. This therapy is not for everyone. A prescription is required.

    For detailed information on the InterStim System implant procedure, refer to the InterStim and InterStim II Implant Manual.

    Device Replacement

    The battery life of the neurostimulator will vary depending on the model and stimulation levels. Clinicians should check the neurostimulator battery level at each follow-up visit.

    For detailed information on replacing the neurostimulators, refer to the InterStim and InterStim II Implant Manual.

    Post Surgery Tined Lead Removal

    If you need to remove the implanted tined lead, the most effective removal technique is to use gentle traction and pull the lead in a straight, not oblique, line from the lead tines. Pull the lead from the lead introducer site above the sacrum not from the neurostimulator pocket site.

    1. Open the neurostimulator pocket site using normal surgical procedure and carefully remove the neurostimulator from the subcutaneous pocket.
    2. Clean the neurostimulator connector block and lead (for Model 3058) or extension connector (for Model 3023) with sterile water; wipe dry with surgical sponges.
    3. For the InterStim model 3058 neurostimulator, insert a torque wrench through the pre-pierced hole in the rubber sealing grommet of the neurostimulator and loosen the setscrew by turning it counterclockwise. Gently retract the lead from the connector block.
      For the InterStim model 3023 neurostimulator: Disconnect the lead from the extension.
    4. Make a small incision at the lead introducer site above the sacral foramen and expose the lead.
    5. From the lead introducer site, gently grasp the lead and pull so that the proximal end of the lead travels from the neurostimulator pocket site through the subcutaneous tissue. Continue pulling until the proximal end of the lead has been removed from the body.
    6. To remove the tined portion of the lead, use gentle traction and pull the lead in a straight, not oblique, line.
    7. Caution: Do not use more than gentle traction to remove the tined lead. Use only gentle traction. More than gentle traction may cause lead breakage, which can result in unretrieved device fragments. If resistance occurs during lead removal, gentle traction should be stopped to reduce the risk of lead breakage. Additional dissection may be needed to release the lead tines and to remove the entire lead.
    8. Remove the entire lead.

    For more information, please refer to the InterStim Tined Leads Implant Manual.

    Procedure Videos

    Medtronic offers the following procedure videos to qualified healthcare professionals. Please register or log in to view these videos.

    Procedural Animations

    Basic Evaluation: Sacral Neuromodulation

    Basic Evaluation: Sacral Neuromodulation

    View an animated presentation of the peripheral nerve evaluation (PNE, also known as the basic evaluation) procedure for Sacral Neuromodulation. Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.

    Advanced Evaluation: Sacral Neuromodulation

    Advanced Evaluation: Sacral Neuromodulation

    View an animation presenting the stage 1 (advanced) evaluation procedure using a tined lead for Sacral Neuromodulation. Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.

    Stage 2 Implant Procedure: InterStim System

    Stage 2 Implant Procedure: InterStim System

    View an animation presenting the stage 2 implant procedure for the InterStim System. The procedure is performed following a successful stage 1 (advanced) evaluation with a tined lead. Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.

    Full Implant Procedure: InterStim System

    Full Implant Procedure: InterStim System

    View an animation presenting the full implant procedure for the InterStim System. The full implant procedure involves implantation of the tined lead and neurostimulator following a successful PNE (basic evaluation). Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.

    Lead Removal After Unsuccessful Evaluation

    Lead Removal After Unsuccessful Evaluation

    View an animation presenting the removal of an InterStim tined lead and connected components following an unsuccessful evaluation. Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.

    Overview of Anatomy

    Pelvic Floor: Anatomy for Sacral Neuromodulation

    Pelvic Floor: Anatomy for Sacral Neuromodulation

    Hear Dr. Kenneth Peters and Dr. Benjamin Girdler discuss the anatomy of the pelvic floor and the leg, which are involved in Sacral Neuromodulation.

    Sciatic and Tibial Nerves: Anatomy for Sacral Neuromodulation

    Sciatic and Tibial Nerves: Anatomy for Sacral Neuromodulation

    See the location of sciatic and tibial nerves in relation to the procedure for Sacral Neuromodulation.

    Sacral Nerves and Sacral Foramina: Anatomy for Sacral Neuromodulation

    Sacral Nerves and Sacral Foramina: Anatomy for Sacral Neuromodulation

    See the location of sacral nerves and sacral foramina in relation to the procedure for Sacral Neuromodulation.

    Office-based Peripheral Nerve Evaluation

    Office-based PNE for Sacral Neuromodulation

    Office-based PNE for Sacral Neuromodulation

    Watch Dr. Karen Noblett demonstrate in-office placement of a temporary lead used for the peripheral nerve evaluation (PNE, also known as the basic evaluation) for Sacral Neuromodulation for Bladder Control.

    PNE: Lead Implantation without Fluoroscopy

    PNE Without Fluoroscopy for Sacral Neuromodulation

    PNE Without Fluoroscopy for Sacral Neuromodulation

    See gynecologist Dr. Brian Raybon perform an in-office peripheral nerve evaluation (PNE, also known as the basic evaluation) procedure for Sacral Neuromodulation without the use of fluoroscopy. He demonstrates how to locate spinal processes, mark the entry point for the needles, and place a temporary lead close to the S3 sacral nerve so that Sacral Neuromodulation can be tested on a patient with bladder control problems.

    PNE: Lead Implantation with Fluoroscopy

    PNE With Fluoroscopy for Sacral Neuromodulation

    PNE With Fluoroscopy for Sacral Neuromodulation

    Watch an overview of the PNE (also known as the basic evaluation) procedure demonstrated by Dr. Brian Raybon and Dr. Thomas Chun to place temporary lead close to the S3 sacral nerve to test Sacral Neuromodulation for Bladder Control.

    PNE With Fluoroscopy: Procedure Preparations

    PNE With Fluoroscopy: Procedure Preparations

    Learn about pre-surgery procedures including proper positioning of the patient, preparing a sterile field, and attaching the screener cable and box. Review contents of the test stimulation kit.

    PNE With Fluoroscopy: Locating S3 Foramen

    PNE With Fluoroscopy: Locating S3 Foramen

    See how to use the cross hairs technique to locate the S3 foramen and place a test stimulation needle with the help of fluoroscopy and measurements devices. Learn how to numb the area, insert needles, and verify stimulation with proper motor and sensory responses from patient.

    PNE With Fluoroscopy: Lead Placement

    PNE With Fluoroscopy: Lead Placement

    See how to insert of temporary leads, recheck sensory responses, remove foramen needles and lead stylets, and secure test leads.

    Sacral Neuromodulation Evaluation: Patient Instructions

    Sacral Neuromodulation Evaluation: Patient Instructions

    Review instructions to share with patients about using programmer, keeping a voiding diary, and proper activities during the evaluation for Sacral Neuromodulation.

    Manuals and Technical Resources

    Prescribing and Pre-Implant Manuals

    Medtronic Sacral Neuromodulation System Information for Prescribers

    This document includes information about contraindications, adverse events, component disposal, and other information regarding Medtronic Sacral Neuromodulation, delivered by the InterStim System.

    Medtronic Sacral Neuromodulation Indications Insert

    This document provides information about indications, warnings, and precautions regarding sacral Sacral Neuromodulation for Bladder Control and Bowel Control, delivered by the InterStim System.

    Medtronic Sacral Neuromodulation Clinical Summary

    This document summarizes the clinical outcomes of Medtronic Sacral Neuromodulation (delivered by the InterStim System) and includes information about the Medtronic-sponsored clinical trials.

    System Overview and Compatibility Insert

    This document includes system and compatibility information about the InterStim and InterStim II systems.

    Test Stimulation Lead/Kit Technical Manual

    This manual includes instructions for use of the InterStim test stimulation lead kit model 3065U and InterStim test stimulation lead model 3057. The instructions cover suggested procedures including preparation, stimulation, and lead removal.

    Test Stimulator Operator Manual

    This document includes a detailed system description, instructions for use, patient instructions, troubleshooting guidelines, and other information about the InterStim test stimulator model 3625.

    Implant Manuals

    InterStim and InterStim II Therapy Implant Manual

    These are the instructions for using the InterStim II model 3058 and InterStim model 3023 neurostimulator systems.

    InterStim Tined Leads Implant Manual

    This manual includes implant procedures and instructions for using the InterStim tined leads models 3093 and 3889.

    Quadripolar Extension Model 3095 Implant Manual

    This manual includes the instructions for use for the quadripolar extension model 3095.

    Clinician Programming Manuals

    N’Vision Clinician Programmer Model 8840 Technical Manual

    This guide presents technical programming information and usage for the N'Vision® clinician programmer model 8840, which is used with InterStim II and InterStim sacral nerve neurostimulators. The manual includes an overview and description, as well as the use, maintenance, troubleshooting, and specifications of the programmer.

    N’Vision Clinician Programming Model 8840 and Application Card Model 8870 Programming Guide

    This programming guide provides instructions on how to use the N'Vision Clinician Programmer model 8840 with the corresponding InterStim application card model 8870 to program, adjust, and troubleshoot the InterStim model 3023 and InterStim model 3058 neurostimulator system.

    Patient Manuals

    InterStim iCon Patient Programmer Patient Manual

    This is the patient user manual for the InterStim iCon® model 3037 patient programmer.

    InterStim iCon Patient Programmer Quick Reference Guide

    This guide includes high-level programming features for the InterStim iCon patient programmer model 3037.

    InterStim Patient Therapy Guide

    This guide is designed to help patients understand how the InterStim System works and to answer questions they may have about how the therapy may affect their day-to-day life.

    MRI Guidelines

    MRI Guidelines for InterStim Therapy Neurostimulation Systems

    This manual provides comprehensive safety information and instructions for MRI head scans with patients implanted with InterStim systems.

    United States