Medtronic InterStim™ Systems with SureScan™ MRI Technology

SureScan™ MRI Technology

Please refer to the InterStim™ MRI Guidelines for comprehensive labeling on conducting an MRI scan at medtronic.com/mri. If the patient is found to have a lead fragment left behind from a previous explant, they may be eligible for an MRI if the fragment meets certain conditions as described in the labeling guidelines.

Patients must bring their programmer and communicator to the MRI appointment. Use the applicable My Therapy app to determine MRI eligibility information. In cases where the implanted system is depleted or at the end of service, the patient may be eligible for a 1.5T head only scan even if they are not carrying a programmer. Please refer to the InterStim™ MRI guidelines for more details.⁴

These instructions apply to:

• Model 97810 InterStim™ Micro neurostimulator with Model 978A1 SureScan™ MRI lead
• Model 3058 InterStim™ II neurostimulator with Model 978B1 SureScan™ MRI lead
• Model 97800 InterStim X™ neurostimulator with Model 978B1 SureScan™ MRI lead

Note: If the patient has a different model number, please see guidelines at medtronic.com/mri. If a patient needs to look up their implant model number, refer them to Medtronic Patient Registration at 800-551-5544. For requests after hours, contact Medtronic Patient Technical Services at 800-510-6735.

[Image: Medtronic logo and icons for My Therapy, Micro My Therapy, and InterStim X My Therapy apps.]

1 BEFORE THE SCAN

Activate MRI Mode

1. On the smart programmer, open the My Therapy App or Micro My Therapy App or InterStim X™ My Therapy App. No impedance check is required prior to the MRI scan.
2. Select "Menu". For Model 97810 InterStim™ Micro neurostimulator only, select "Battery" within the menu. Confirm the neurostimulator is charged to a minimum of 30% prior to MRI. Do not proceed if neurostimulator is less than 30% charged.
3. Select "MRI" within the menu. Note: If MRI is not shown in the menu, refer to InterStim™ MRI Guidelines for eligibility.
4. Follow the instructions on the programmer then select "Activate."
5. The MRI mode activation screen appears. Therapy is off. The text and symbols on screen indicate the system is full-body MRI eligible.

[Image: Two smartphone screens. The first shows "ACTIVATE MRI MODE" with instructions to place the communicator over the device and press ACTIVATE. The second shows "MRI Mode is Activated" and "MR Conditional Full Body Scan Eligible" with system details and an "DEACTIVATE" button.]

2 MRI SPECIFICATIONS

There are no restrictions on MRI manufacturers

• Approved for the commonly used MRI systems:
  • 3T horizontal closed cylindrical system
  • 1.5T horizontal closed cylindrical system
• MRI magnetic field gradient specifications:
  • Max gradient slew rate ≤ 200 T/m/s per axis
  • Max spatial field gradient: 20 T/m (2000 gauss/cm)
• Scan time limit: After 30 minutes of accumulated scan time, allow 5 minutes of cooling.
• Patient body temperature: Confirm that the patient's body temperature is ≤100 °F. Do not use blankets.
• Patient position: Position the patient in a prone or supine position in the MRI bore.

3 SCAN PREPARATION

• RF Transmit Coils:
  • whole body integrated transmit coil.
  • detachable transmit/receive head or lower extremity volume coil.
• RF Receive Coils: Unrestricted
• Scanner Operating Modes:
  • Normal Operating Mode
  • First Controlled Operating Mode
• RF Exposure Limits at or Superior to C7 (1.5T and 3T):
  • Up to the First Controlled mode SAR limit (4 W/kg whole body or 3.2 W/kg head)
• RF Exposure Limits Inferior to C7:
  • 1.5T
  • ≤ 4 uT B1+rms using the whole-body RF coil.
  • ≤ 2W/kg whole body SAR if B1+rms is not displayed on the scanner.
  • First Controlled mode SAR limit when using a detachable transmit/receive lower extremity volume coil.
  • 3T
  • ≤ 2 uT B1+rms using the whole-body RF coil.
  • ≤ 1.4 W/kg whole body SAR if B1+rms is not displayed on the scanner.
  • First Controlled mode SAR limit when using a detachable transmit/receive lower extremity volume coil.

Please note: 3T RF whole body transmit coil – MRI systems using two transmit channels may operate in multichannel-2 (MC-2) or circularly polarized (CP) modes. Systems that use more than two transmit channels have not been studied, but such systems could be operated in CP or MC-2 modes, if available.

4 AFTER THE SCAN

Deactivate MRI mode. Turn therapy back on.

Once MRI mode has been deactivated and therapy turned on, the patient's stimulation automatically increases to the previous setting.

[Image: Three smartphone screens illustrating the MRI mode deactivation process. The first shows "MRI Mode is Activated" with a "DEACTIVATE" button. The second shows a confirmation prompt: "Are you sure you want to deactivate MRI mode?" with "DEACTIVATE" and "CANCEL" buttons. The third shows "MRI MODE DEACTIVATED" with a prompt "Do you want to turn therapy on?" offering "YES" and "NO" options.]

Designed for safety

Patient safety is our top priority.

[Image: A patient is positioned within an MRI scanner, with a technician attending. Surrounding this central image are circular callouts displaying statistics: "Full-body 1.5T|3T MRI scans", "20+ years of MRI research", "1.2 million scanning scenarios", and "10 million simulated patient scans".]

Simple and convenient

The SureScan™ MRI systems are designed to streamline MRI scans for patients, technicians, and clinic staff.

• ✔️ No impedance checks are required prior to MRI scans.
• ? MRI mode is easy to activate on a smart programmer.³
• ? All Medtronic InterStim™ systems with SureScan™ technology have the same MRI conditions.

Dedicated engineers, scientists, and technicians working together at our MRI Center of Excellence and MRI testing lab developed proprietary SureScan™ MRI technology. This unique design allows patients receiving sacral neuromodulation with the InterStim™ systems to have an MRI scan with confidence.

[Image: A technician wearing glasses is shown working on electronic components with a magnifying glass and soldering equipment.]

References and Information

• Combination of body model, MRI manufacturer, implant location, lead length, scanner type and stimulator type.
• Medtronic data on file - result of animal studies combined with lab data, computational modeling and statistical methods.
• MRI SureScan™ technical manuals on medtronic.com/mri.
• Medtronic MRI Guidelines for InterStim™ systems, M980291A032 Rev A.

See the device manual for detailed information regarding the instructions for use, implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative or consult the Medtronic website at medtronic.com.

Indications for Use:

Sacral Neuromodulation delivered by the InterStim™ system for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

Sacral Neuromodulation delivered by the InterStim™ system for Bowel Control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.

Contraindications for Urinary Control and for Bowel Control:

• Diathermy.
• Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.

Warnings/Precautions/Adverse Events:

• For Urinary Control: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 16; or for patients with neurological disease origins.
• For Bowel Control: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 18; or for patients with progressive, systemic neurological diseases.
• For Urinary Control and for Bowel Control: The system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, theft detectors/ screening devices. Adverse events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations, including jolting or shock sensations. Patients should be assessed preoperatively for the risk of increased bleeding.

For full prescribing information, please call Medtronic at 1-800-328-0810 and/ or consult Medtronic's website at www.medtronic.com. Product technical manual must be reviewed prior to use for detailed disclosure. USA Rx Only. Rev 0517