Our Products, Your Patients
Medtronic Sacral Neuromodulation for Pelvic Floor Dysfunction
Image: A woman smiling, alongside Medtronic InterStim system devices (a programmer and a neurostimulator).
MEDTRONIC SAKRAL NEUROMODULATION WITH THE INTERSTIM® SYSTEM
InterStim® II 3058 Implantable Neurostimulator
The neurostimulator is used with a Tined Lead Electrode Model 3889 and the InterStim iCon Patient Programmer Model 3037. The programmable neurostimulator delivers stimulation impulses via an electrode. Stimulation settings are saved as programs, which are specific combinations of pulse duration, frequency, and amplitude based on the electrode pole configuration (up to 4 electrode poles).
Sterile Contents:
- (1) Neurostimulator
- (1) Torque Wrench
Non-Sterile Contents:
- Product Documentation
Technical Data:
| Dimensions | |
|---|---|
| Height | 44 mm |
| Length | 51 mm |
| Thickness | 7.7 mm |
| Weight | 22 g |
| Volume | 14 cm³ |
| Parameter | Value |
|---|---|
| Battery Life | Dependent on selected parameters and usage |
| Number of Screws | 1 |
| Maximum Number of Electrode Poles | 4 |
| Frequency | 14 Hz (default setting), 49 settings between 2.1 and 130 Hz |
| Pulse Duration | 210 µs (default setting), 60 to 450 µs in 30 µs steps |
| Amplitude | 0 to 8.5 V (in 0.05 V or 0.1 V steps) |
| Number of Programs | 4 |
| Other Functions | Cyclic programming, SoftStart/Stopp |
| Compatible Electrodes | 3889-28 or 3889-33 or 3889-41 |
| Extension | Direct electrode connection, no extension required |
| Implantation Depth | 2.5 cm |
Key Benefits:
- Therapy for pelvic floor dysfunctions such as overactive bladder or fecal incontinence.
- Minimally invasive testing and implantation with a short hospital stay.
- Over 200,000 patients worldwide have received a Medtronic InterStim System for sacral neuromodulation since the CE mark in 1994.
InterStim® iCon™ 3037 Patient Programmer
Small handheld device that allows patients to turn the InterStim II Neurostimulator on/off, change the amplitude within physician-defined limits, and switch between up to 4 physician-programmed settings.
Sterile Contents:
- None
Non-Sterile Contents:
- (1) InterStim iCon Patient Programmer
- (1) Protective Pouch
- (2) AAA Batteries (LR03)
- Product Documentation
Technical Data:
| Dimension/Parameter | Value |
|---|---|
| Height | 9.4 cm |
| Length | 5.6 cm |
| Thickness | 2.8 cm |
| Weight | 111 g |
| System | Battery life 2 months (average) with alkaline batteries |
| Number of Programs | 4 |
Key Benefits:
- Simplifies patient management and programming.
- Stores usage data (duration of use, programs used) between follow-up appointments.
- Stores patient data and program history.
- Settings are easily readable on the LCD screen.
- Allows patients to adjust amplitude within physician-set limits and switch between up to 4 predefined programs.
- Controls the neurostimulator (on/off).
- Compatible with the InterStim II 3058 Neurostimulator.
InterStim® Tined Lead 3889
Tined Lead Anchor Electrode. Four-pole electrode for permanent stimulation with four anchor rows for electrode fixation, available in lengths 28 cm, 33 cm, or 41 cm.
Sterile Contents:
- (1) Electrode with straight stylet
- (2) Stylets (long & curved; short)
- (1) Percutaneous Extension
- (1) Test Stimulation Cable
- (1) Tunneling Tool (length 20/33 cm - for models -28 and -33: 20 cm; model -41: 33 cm)
- (1) Tunneling Tip
- (1) Tube
- (1) Connector Protection Cap
- (1) Torque Wrench
Non-Sterile Contents:
- Product Documentation
Technical Data:
| Characteristic | Value |
|---|---|
| Electrode Length | 20 to 41 cm |
| Electrode Shape | Straight |
| Electrode Diameter | 1.27 mm |
| Electrode Connector | Inline |
| Number of Electrode Poles | 4 |
| Form of Electrode Poles | Cylindrical/Spiral |
| Electrode Pole Length | 3 mm (4x) |
| Pole Spacing | 3 mm |
| Number of Leads | 4 |
Implanted Materials in contact with human tissue:
| Material | Component |
|---|---|
| MP35N | Conductor wires, Proximal contact rings |
| Polyurethane adhesive | Electrode ends |
| Platinum/Iridium | Electrode poles |
| Polyurethane | Anchors |
| Silicone rubber | Connector protection cap |
| Insulation | Conductor wires: Fluoropolymer, Outer sheath: Polyurethane |
Lead Resistance:
| Length | Resistance |
|---|---|
| 28 cm | max. 125 Ohm |
| 33 cm | max. 145 Ohm |
| 41 cm | max. 165 Ohm |
*Note: All values are approximate. Electrode resistance is proportional to length, which may limit deliverable amplitude.
Key Benefits:
- The exclusive Medtronic Tined Lead Anchor Electrode enables positioning under visual control using radiopaque markers (fluoroscopy).
- Minimizes the number of intraoperative steps, contributing to a shorter OR and healing time.
- Features anchors for fixation and can be easily removed minimally invasively.
- Allows better steering of the electrode during placement via the exclusive curved stylet.
PNE-Test Electrode 3059
Test Electrode for Percutaneous Nerve Evaluation (PNE). Flexible, thin electrode for basic evaluation (PNE), easily removable without surgery after the test phase.
Sterile Contents:
- (1) Test Electrode or (6) individually packaged Test Electrodes
Non-Sterile Contents:
- Product Documentation
Technical Data:
| Characteristic | Value |
|---|---|
| Model Number | 3059 01 (1 pc) or 3059 06 (6 pcs) |
| Electrode Length | 41 cm |
| Electrode Shape | Straight, coiled |
| Electrode Diameter | 0.65 mm (max.) |
| Depth Markings | 2 |
| Electrode Connector Pin Diameter | 0.60 mm |
| Number of Electrode Poles | 1 at the distal tip |
| Electrode Pole Length | 10 mm |
| Electrode Pole Area | 11 mm² |
| Material: Conductor wires | Stainless Steel |
| Electrode poles | Stainless Steel |
| Stylet | Stainless Steel or Tungsten |
| Electrode connector pin | Stainless Steel |
| Electrode insulation | Fluoropolymer |
| Lead Resistance | 150 Ohm (max.) |
| Implantation Method | 20-G needle |
| Materials in contact with human tissue | Stainless Steel, Fluoropolymer |
Verify® External Neurostimulator 3531
Verify® Test Module. Small, lightweight, programmable device that delivers stimulation impulses during the test phase via one or more electrodes (not simultaneously), in conjunction with the Model 3531 Controller.
Sterile Contents:
- None
Non-Sterile Contents:
- (1) Verify Test Module (External Neurostimulator)
- (1) Belt for Test Module
- (4) AAAA Batteries
- Product Documentation
Technical Data:
| Characteristic | Value |
|---|---|
| Length | 51 mm |
| Width | 43 mm |
| Thickness | 15 mm |
| Weight (with batteries) | 53.9 g |
| Output Socket | 21-pin |
| Power Source | 2 x AAAA Alkaline Batteries |
| Battery Life | Minimum 14 days with alkaline batteries* |
| Protection Class against electrical shock | Type BF |
| Housing Material | Polycarbonate/ABS plastic blend |
| Automatic Shut-off | Connector cable disconnected |
| Emergency Shut-off | Disconnect connector cable or hold button for 2 seconds |
| Environmental | Value |
|---|---|
| Minimum Temperature | 9°C |
| Maximum Temperature | 43°C |
| Storage | Room Temperature |
| Maximum Humidity | 95% (non-condensing) |
| Minimum Atmospheric Pressure | 50 kPa |
| Maximum Atmospheric Pressure | 106 kPa |
| Ingress Protection Rating | IP24 |
| Communication | Value |
|---|---|
| Communication | Wireless Bluetooth Technology |
| Compatibility | Details |
|---|---|
| Compatible Accessories | 3537 Controller |
| Compatible Electrodes | 357625/357664 Twist-Lock Connector Cable, 357501/357506 Test Stimulation Cable with Mini-hooks, 367637/367675 Patient Cable with Neutral Electrode, 357937/357975 Patient Cable without Neutral Electrode, 3059 PNE Test Electrode, 3889 Tined Lead Anchor Electrode |
| Wearing the Test Module | On the included belt |
| Conformity Declaration | Directive 1999/5/EC for Radio and Telecommunications Terminal Equipment and Directive 93/42/EEC for Medical Devices |
*Battery life based on 24 hours stimulation/day with 1 program: Impedance = 1200 Ω, Amplitude = 4.2 mA, Pulse Duration = 210 µs, Frequency = 14 Hz and multiple communication events.
Verify® Controller 3537
Controller for the Verify® Test Module. Wireless, lightweight handheld device with a touchscreen.
Sterile Contents:
- None
Non-Sterile Contents:
- (1) Controller
- (1) Protective Pouch
- (2) AA Batteries
- Product Documentation
Technical Data:
| Characteristic | Value |
|---|---|
| Power Source | 2 AA Alkaline Batteries (non-rechargeable, LR03) |
| Operating Temperature | +9°C to +43°C |
| Storage | Room Temperature |
| Dimensions | approx. 12.0 x 6.0 x 2.4 cm |
| Weight (incl. batteries) | approx. 150 g |
| Battery Life | 2 weeks (average) with alkaline batteries |
| Communication Transmission | Real-time |
| Compatible With | 3531 Verify Test Module |
| Display | Touchscreen, color |
| Communication | Wireless Bluetooth Technology |
| Power (once batteries are inserted) | Controller is continuously "on" |
| Display dims after 15 seconds of inactivity | |
| Display turns off and locks after 2 minutes of inactivity |
Features:
- Usage Log
- Automatic Error Detection
- Automatic Cable Detection
- 3 Programs when using a Tined Lead Electrode (3889) during the test phase
- Electrode switching (side) during PNE testing
Patient Cables for the Verify® System
Test Cables for Intraoperative Testing and Test Phase. Cables are used for motor response testing or connecting the electrode(s) to the Verify Test Module during the test phase, depending on the version.
Technical Data:
| Item | Length |
|---|---|
| 357501 (1 pc) or 357506 (6 pcs) Verify Test Stimulation Cable with Mini-hooks (sterile) | 218 cm |
| 367637 Patient Cable with Neutral Electrode (PNE Test) | 37 cm |
| 367675 Patient Cable with Neutral Electrode (PNE Test) | 75 cm |
| 357937 Patient Cable without Neutral Electrode (PNE Test) | 37 cm |
| 357975 Patient Cable without Neutral Electrode (PNE Test) | 75 cm |
| 357625 Twist-Lock Connector Cable (Tined-Lead Test) | 25 cm |
| 357664 Twist-Lock Connector Cable (Tined-Lead Test) | 64 cm |
Accessories for the Verify® System
309101 PNE Verify® Test Stimulation Kit
- Sterile Contents: (1) PNE Test Electrode Model 3059, (1) Test Stimulation Cable Model 3575, (2) 20-G Needles, 9 cm length, (1) 20-G Needle, 12.5 cm length, (3) Foam Swabs with Holder, (1) Ruler, (1) Sterile Pen, (4) Drapes, (7) Gauze Swabs, (7) Tegaderm, (1) Syringe, (1) Injection Needle, (1) Tray.
- Non-Sterile Contents: (1x2) Neutral Electrodes, (1) 357975 Patient Cable without Neutral Electrode, (1) 367675 Patient Cable with Neutral Electrode, Product Documentation.
3560019 Replacement Belt for Verify® Test Module
- Sterile Contents: None.
- Non-Sterile Contents: (1) Belt, Product Documentation.
37094 Silicone Covers for Verify® Controller
- Sterile Contents: None.
- Non-Sterile Contents: (6) Assorted colored Silicone Covers. Box of 6 pcs.
Accessories for the InterStim® System
041826 Self-Adhesive Neutral Electrode (Non-Sterile) - Box of 10x2 pcs
Flexible carbon electrode.
- Sterile Contents: None.
- Non-Sterile Contents: (10x2) Self-adhesive Neutral Electrodes, Product Documentation.
041828 Foramen Needle - Box of 6 pcs
Insulated needle with 1 cm depth markings, opaque shaft with locked stylet. Needle with Quincke tip (bevelled).
- Sterile Contents: (6) 20-G, 9.0 cm long Foramen Needles.
- Non-Sterile Contents: Product Documentation.
041829 Foramen Needle - Box of 6 pcs
Insulated needle with 1 cm depth markings, opaque shaft with locked stylet. Needle with Quincke tip (bevelled).
- Sterile Contents: (6) 20-G, 12.5 cm long Foramen Needles.
- Non-Sterile Contents: Product Documentation.
042294 Electrode Introducer - Box of 6 pcs
- Sterile Contents: 6 packs each containing (1) Introducer Sheath, (1) Guidewire, 30 cm, (1) Dilator.
- Non-Sterile Contents: Product Documentation.
3550-05 Percutaneous Extension
- Sterile Contents: (1) Percutaneous Extension, 4-pole, (1) Tunneling Tool, (1) Tunneling Tip, (1) Tube.
- Non-Sterile Contents: Product Documentation.
3550-18 Electrode Introducer Set for Tined Lead Anchor Electrode Implantation
- Sterile Contents: (2) 9 cm Foramen Needles, (1) Guidewire, 30 cm, (1) Dilator, (1) Introducer Sheath, (1x2) Self-adhesive Neutral Electrodes, (1) Long Test Cable, (1) Patient Cable.
- Non-Sterile Contents: Product Documentation.
3550-80 Torque Wrench & Cap Set
- Sterile Contents: (1) Torque Wrench, (1) Protection Cap for Extension Model 3095.
- Non-Sterile Contents: Product Documentation.
37092 Antenna
Antenna with 91.5 cm cable for optional use with the 3037 InterStim iCon Patient Programmer.
- Sterile Contents: None.
- Non-Sterile Contents: (1) Antenna, Product Documentation.
8840 N'VISION® Physician Programmer
N'VISION® Physician Programmer. The N'Vision Physician Programmer is a small, portable handheld programmer. With a touchscreen for data entry, a detachable telemetry head, and few buttons, it is optimized for simple and pleasant handling. The N'Vision System requires at least one N'Vision Programmer (8840) and one N'Vision Software Card (e.g., 8870 NNC01). With the 8870 NNC01 software card, the N'Vision is compatible with the InterStim and Enterra Systems.
Sterile Contents:
- None
Non-Sterile Contents:
- (1) Programmer with Pouch
- (4) Batteries
- Product Documentation
Technical Data:
| Characteristic | Value |
|---|---|
| Power Source | Standard 4 AA Alkaline Batteries (LR6) |
| Battery Life | 40 hours with typical use |
| Replacement Battery for Clock | Lithium button cell Type BR1225 |
| Length | 22 cm |
| Width | 10 cm |
| Height | 4 cm |
| Weight (without batteries) | 680 g |
| Housing Material | Thermoelastic resin and magnesium |
| Telemetry Module Cable Length | 90-100 cm |
| Screen Color | 4 Grayscales |
| Screen Size | 240 x 640 pixels |
| Serial Interface | IR communication port conforming to Infrared Data Association (IrDA) 1.0 at baud rates of 9600 and 57600 |
Key Benefits:
- Fast programming for minimal time expenditure.
- Simple and clear user interface.
- Customizable reports reduce resource needs and waste.
- Facilitates and automates therapy testing via program libraries.
- Enables effective patient management.
- Displays a summary of programs and usage data.
- Special alerts indicate common problems during therapy.
- Patient data can be transferred during implant replacement.
8870 NNC01 N'VISION® Software Card
COMPATIBLE WITH THE INTERSTIM® SYSTEM AND THE ENTERRA® SYSTEM. For use with the 8840 N'Vision Physician Programmer. Contains the necessary software applications to program implanted Medtronic neurostimulators for sacral neuromodulation and electrical gastrostimulation. Please speak with your responsible Medtronic representative regarding the current software version.
Sterile Contents:
- None
Non-Sterile Contents:
- (1) Software Card
- (1) Storage Case
- Product Documentation
8580 N'VISION® Report Link
N'VISION® REPORT LINK FOR PRINTING PROGRAMMING REPORTS. For use with the 8840 N'Vision Physician Programmer. Electronically transfers session reports from the programmer (8840) for storage on the PC. Reports can be saved as PDF files in the electronic patient record or printed in full page on a local or network printer.
Sterile Contents:
- None
Non-Sterile Contents:
- (1) CD
- (1) USB-IR Adapter Cable
- Product Documentation
Key Benefits:
- Organize and print data directly from your PC.
- With the N'Vision Report Link, physicians can transfer data from the N'Vision 8840 or any patient programmer directly to a computer.
- Session reports and screen displays are transferred and saved as standard PDF files. They can also be printed on any printer.
- The N'Vision Report Link System enables:
- Easy connection to the computer.
- Convenient transfer of session reports.
- Digital archiving.
- Full-page printing of session reports and thus programming settings.
IMPORTANT SAFETY INFORMATION
InterStim® Therapy for Urinary and Bowel Control: Before use, familiarize yourself with the User Manual and Technical Documentation. Indications: InterStim® Therapy is indicated for the treatment of chronic, refractory (functional) pelvic floor and lower urinary or bowel tract disorders. Contraindications: Diathermy. Implantation of the InterStim® System is contraindicated in patients for whom adequate stimulation effect was not achieved during the stimulation test or who are unable to operate the neurostimulator. Precautions / Adverse Events: No information is available on safety and efficacy in patients under 16 years of age, during pregnancy or childbirth, or on effects on the fetus. The system may be interfered with or interfere with devices supporting heart function, electrocautery, defibrillators, ultrasound devices, radiation therapy, magnetic resonance imaging, merchandise security systems, and security gates. Possible adverse events include: pain at implantation sites, new onset pain, lead migration, infections, technical malfunctions, device failures, impairment of bowel function and/or elimination function, unwanted stimulation, or electric shock-like sensations. Medtronic will gladly provide you with complete prescription information. A complete list of indications, contraindications, warnings, and precautions can be found in the technical manual.
Contact Information:
- Europe Medtronic International Trading Sàrl. Route du Molliau 31 Case postale CH-1131 Tolochenaz Tel: +41 (0)21 802 70 00 Fax: +41 (0)21 802 79 00
- Deutschland Medtronic GmbH Earl-Bakken-Platz 1 DE-40670 Meerbusch deutschland@medtronic.com Deutschland Telefon: +49 (0)2159 81 49 0 Telefax: +49 (0)2159 81 49 100
