Medtronic InterStim MRI Guidelines
This document provides essential guidelines for performing Magnetic Resonance Imaging (MRI) examinations on patients with implanted Medtronic InterStim™ systems. It is crucial to read this entire manual before conducting any MRI scan.
These instructions apply exclusively to Medtronic InterStim implanted systems and do not cover other implantable products or devices. Medtronic does not make any safety claims for MRI scans involving modified InterStim system components or non-Medtronic components.
For questions, please contact Medtronic using the information provided at the back of this manual.
Schedule MRI
To schedule an MRI for a patient with a fully implanted Medtronic InterStim system:
- Identify the model numbers of the implanted Medtronic neurostimulator and lead.
- Refer to Table 1 for potential MRI scan-type eligibility for scheduling purposes.
- If the neurostimulator model number is unknown, the patient should check their Medtronic patient ID card, consult their clinician, or contact Medtronic support.
- If the lead model number is unknown, schedule the patient for the most conservative scan available based on the identified neurostimulator model number.
Prior to the MRI appointment, patients should:
- Consult with the clinician managing their InterStim system.
- Bring their patient control device and patient ID card to the MRI appointment.
- Recharge a rechargeable neurostimulator before the MRI appointment.
- Inform the MRI clinician about their implanted device.
Neurostimulator and Lead Model Numbers
Medtronic InterStim systems have been found to be MR Conditional through non-clinical testing. These guidelines are for approved indications to safely perform MRI scans on patients with a fully implanted Medtronic InterStim system for sacral neuromodulation therapy.
These guidelines apply to neurostimulator model numbers listed in Table 1, when implanted as a system including a neurostimulator and lead (and extension, if applicable).
IMPORTANT: Review the entire manual, including the "ELIGIBILITY IDENTIFICATION" section and the checklist starting on page 12, to determine the patient's MRI scan-type eligibility and appropriate scan conditions.
Table 1. InterStim systems – implanted neurostimulator and lead model numbers associated with these MRI guidelines
Neurostimulator | Lead | MRI scanner |
---|---|---|
Model 97810 InterStim Micro SureScan™™ MRI rechargeable neurostimulator | Model 978A1 SureScan lead | If eligible, 3-Tesla (T) and 1.5-T MR Conditional. Check "ELIGIBILITY IDENTIFICATION" on page 12 before scanning. Ask the patient to recharge the neurostimulator before the MRI appointment. |
Model 97800 InterStim X OR Model 3058 InterStim II neurostimulator | Model 978B1 SureScan lead | If eligible, 3-T and 1.5-T MR Conditional. Check "ELIGIBILITY IDENTIFICATION" on page 12 before scanning. |
[Type of lead:] | No need to determine the InterStim lead model for this scenarioa. | If eligible, 1.5-T MR Conditional Head Scan Eligible with Detachable Head Transmit/Receive Volume Coil. Check "ELIGIBILITY IDENTIFICATION" on page 12 before scanning. |
Model 3023 InterStim neurostimulator | No need to determine the InterStim lead model for this scenarioa. | If eligible, 1.5-T MR Conditional Head Scan Eligible with Detachable Head Transmit/Receive Volume Coil only. Check "ELIGIBILITY IDENTIFICATION" on page 12 before scanning. |
No MRI scans for serial numbers: Less than NBV132955H, Between NBV133037H and NBV133063H, Between NBV628045S and NBV628263S. Note: If a programmer is used to check the neurostimulator serial number, the letter suffix (H or S) may not be included in the serial number displayed. | ||
Model 7427T InterStim Twin neurostimulator | No MRI scans | No MRI scans |
a When implanted per approved indications, InterStim system components are outside of the head coil.
Non-Medtronic components or accessories are not supported by these MRI guidelines.
Patient ID Card
Patients should provide their most up-to-date patient ID card at the MRI appointment. MRI personnel can use this card to identify Medtronic as the manufacturer.
Obtain the Latest MRI Guidelines Labeling
Always obtain the latest MRI guidelines. Visit www.medtronic.com/mri and enter the neurostimulator model number. Guidelines received directly from the website or Medtronic on the same day as the appointment are the most up-to-date.
External Control Device
For Medtronic InterStim systems, external control devices (patient control device, handset with therapy app, or clinician programmer) are used to determine MRI scan-type eligibility and prepare the system for the scan.
IMPORTANT: Ensure the patient brings a patient control device to the MRI appointment, as it is necessary for determining eligibility per the "ELIGIBILITY IDENTIFICATION" section.
For the Model 3023 neurostimulator, if the patient uses a control magnet to turn the system on or off, a clinician must first disable the magnet switch using the Model 8840 Clinician Programmer.
Patient Control Device Identification and Operation: Refer to "ELIGIBILITY IDENTIFICATION" on page 12 and the identification checklist. If the patient control device cannot communicate with the implanted system, MRI scan-type eligibility cannot be confirmed. Research the implanted system configuration from medical records or see "Appendix C: X-ray identification – InterStim systems" for guidance. Unless the implanted system configuration is known and deemed safe for MRI under specific conditions, do not conduct the scan.
Note: Illustrations of patient control device hardware are representative; actual hardware may differ.
Image Artifacts and Distortion (for full-body eligible scans only)
Significant image distortion can occur due to the presence of the neurostimulator and leads. Consider these factors when selecting the field of view and imaging parameters, and when interpreting MRI images.
General Information on MRI Procedures and Neurostimulation System Interactions
MRI systems generate electromagnetic fields that can interact with implanted neurostimulation system components. These interactions, particularly heating, can be hazardous and lead to serious or permanent patient injury. The following information outlines potential interactions and control measures to minimize risks.
Information for Prescribers
Risks Associated with Implanted Neurostimulation Systems in the MRI Environment
Exposing a patient to MRI settings other than those specified in this manual may injure the patient or damage the neurostimulator. Potential risks include:
- Heating: RF induced currents can cause lead electrode heating, resulting in tissue damage. Time-varying magnetic field gradients may also heat the neurostimulator. This applies even with only a lead or extension implanted. Factors increasing risk include exceeding B1+rms or SAR limits, exceeding continuous scan time, or insufficient wait time.
- Induced Stimulation: Gradient magnetic and RF fields can induce energies onto the lead system, potentially causing unintended stimulation (tingling, shocking, jolting).
- Magnetic Field Interactions: The magnetic material of the implanted system may experience force, vibration, and torque effects. Patients might feel a mild tugging or vibration, or the neurostimulator may move within the implant pocket. Patients with recent implant incisions should be monitored for discomfort.
- Device Damage: Static, pulsed gradient, or pulsed RF fields from the MRI may permanently damage the neurostimulator, requiring explant or replacement.
- Device Interactions: MRI may affect neurostimulator operation, potentially requiring reprogramming by the clinician programmer after the scan, especially if the scan resets parameters to power-on-reset (POR) settings.
Warnings
MRI During Therapy Evaluation (Temporary Evaluation): Ensure all temporary evaluation components are explanted if an MRI scan is required. Do not prescribe MRI for patients undergoing therapy evaluation or with non-fully implanted components. MRI has not been evaluated with therapy evaluation components. External neurostimulators are unsafe in the MR environment.
Limitations for Scanning Patients with Fully Implanted Neurostimulation Systems:
- Before an MRI scan, determine if the patient has multiple active medical device implants. Use the most restrictive MRI exposure requirements if multiple implants are present. Contact manufacturers if unsure. If implant presence is unclear, use X-ray to determine type and location.
- If the system is removed, ensure all portions are removed before the MRI scan. Partial systems can still cause MRI interactions like RF heating, potentially leading to tissue damage and serious injury.
Failure to follow warnings and conditions may result in patient discomfort, device damage, or serious/permanent patient injury due to excessive heating or other risks.
Precautions
MR Unsafe External Devices: Do not allow the following Medtronic external devices into the MRI scanner room:
- Patient control devices (programmer, handset, communicator)
- Control magnet for Model 3023 neurostimulator
- Recharger
- External neurostimulator
- Clinician programmer
ELIGIBILITY IDENTIFICATION
Do not proceed with MRI instructions if the patient lacks a patient control device for their InterStim system. A patient control device is necessary for the MRI clinician to determine eligibility.
Identify the Patient's MRI Scan-Type Eligibility
Use the eligibility identification checklist to determine the patient's MRI scan-type eligibility and the appropriate MRI equipment, scan requirements, and RF field requirements.
MRI scan-type eligibility depends on factors related to the patient's implanted neurostimulation system.
Eligibility Identification Checklist
If the patient provides an MRI eligibility form from their clinician, use it to confirm information on the patient control device.
1. What type of patient control device did the patient bring?
Patient control device A with MRI icon:
- Ask the patient to tap ☰ in the patient therapy app Home screen.
- Select MRI and activate MRI mode. (See Appendix A, "Part 1. Patient Control Device A with MRI icon: Activating MRI Mode" on page 28).
- Follow on-screen instructions to proceed to step 2.
- If no MRI icon is shown, proceed to "Patient control device A without MRI icon".
Patient control device A without MRI icon:
- Ask the patient to tap ☰ in the patient therapy app Home screen.
- If no MRI icon is shown, go to "Head-only eligible – Handset identification" on page 22.
Patient control device B:
- Go to "Head-only eligible – Handset identification" on page 22.
No patient control device:
- STOP. These guidelines do not apply as a patient control device is required. Reschedule the MRI appointment with a patient control device or contact the managing clinician.
2. Determine the option displayed on patient control device A with MRI icon:
- MRI Mode is Activated (MR Conditional Full Body Scan Eligible): Go to "Full-body eligible MRI scan conditions" on page 16.
- MRI Mode is Activated (MR Conditional Head Scan Eligible with Transmit/Receive Head Coil): Go to "Head-only eligible MRI scan conditions" on page 22.
- MRI Mode is Activated (MRI eligibility cannot be determined): STOP. Contact the managing clinician before the MRI scan. Instruct the patient to deactivate MRI mode at the end of the appointment.
- Not Ready for MRI Scan (Not Eligible): STOP. No MRI scans. Contact the managing clinician.
Notes:
- The "consult instructions for use" symbol (ⓘ) means "consult the MRI guidelines for this neurostimulation system."
- For information code interpretation on the MRI Mode screen, call Medtronic support.
- Do not deactivate, exit MRI mode, or turn therapy on with the patient control device until after the MRI scan is complete and the patient is outside the scanner room.
Full-Body Eligible MRI Scan Conditions
MR Conditional Full Body Scan Eligible
Confirm via the "ELIGIBILITY IDENTIFICATION" section (page 12) that the patient's system is MR Conditional for full-body scans. Patients identified as "MR Conditional Full Body Scan Eligible" can undergo 3-T and 1.5-T scans of any anatomy part if all specific conditions are met.
Full-body eligible – MRI Equipment and Scan Requirements
Use Table 2 (page 17) to track patient model numbers and MRI equipment. Check boxes as applicable.
Warning: Scans must adhere to the MRI equipment, scan, and RF field requirements specified in this manual. Failure to comply may result in patient discomfort, device damage, or serious/permanent injury due to excessive heating or other risks.
General MRI Conditions:
- Identify scan-type eligibility using the patient control device. Do not proceed without full-body eligibility confirmation.
- Activate MRI mode using the patient control device.
- Ensure the patient's rechargeable neurostimulator is sufficiently charged.
Table 2. Model 97810, Model 97800, and Model 3058 full-body eligible conditions – 3-T and 1.5-T MRI equipment and scan requirements
MRI scanner | |
---|---|
Confirm the neurostimulator and lead model numbers on the patient control device. [Select one:] | |
Confirm battery status (Model 97810 neurostimulator only). | Confirm with the patient that the neurostimulator is charged to at least 30% before scanning. Do not proceed if not sufficiently charged. |
Confirm scan-type eligibility and that MRI mode is activated on the patient control device. | Placing the device in MRI mode turns therapy off. The text and symbols indicate full-body MRI scan eligibility and that the system is in MRI mode. MR ☍ ⓘ MR Conditional Full Body Scan Eligible |
MRI system types [Select one:] | |
Maximum gradient slew rate specification | ≤ 200 T/m/s per axis |
Maximum spatial field gradient | 20 T/m (2000 gauss/cm) |
Scan time limit | Maximum 30 minutes of continuous scan time, followed by a 5-minute wait time if limit is reached. |
Proceed to MRI scan regions and RF field requirements in Table 3 (3-T) on page 18 or Table 4 (1.5-T) on page 19.
Table 3. Full-body eligible 3-T MRI scan regions and RF field requirements
① Depicts a transverse plane at the C7 vertebra.
Scan region | 3-T RF coil | 3-T RF exposure level |
---|---|---|
② At or superior to the C7 vertebra [Select one:] | 3-T: Normal Operating Mode or First Level Controlled Operating Mode | |
③ Inferior to the C7 vertebra [Select one:] | 3-T: B1+rms ≤ 2.0 μT. Values before scanning; for MRI scanners that do not report B1+rms, limit SAR to ≤ 1.4 W/kg. |
Note: 3-T MRI systems using two transmit channels (or fewer) may operate in Multichannel-2 (MC-2) or Circularly Polarized (CP) configurations. Systems using more than two transmit channels have not been studied but could be operated in CP or MC-2 configurations.
Table 4. Full-body eligible 1.5-T MRI scan regions and RF field requirements
① Depicts a transverse plane at the C7 vertebra.
Scan region | 1.5-T RF coil | 1.5-T RF exposure level |
---|---|---|
② At or superior to the C7 vertebra [Select one:] | 1.5-T: Normal Operating Mode or First Level Controlled Operating Mode | |
③ Inferior to the C7 vertebra [Select one:] | 1.5-T: B1+rms ≤ 4.0 μT. Values before scanning; for MRI scanners that do not report B1+rms, limit SAR to ≤ 2.0 W/kg. |
Note: RF Whole Body Transmit Coil - 1.5-T MRI systems should only be operated in CP configuration.
Proceed to "Full-body eligible – Preparing the patient before the MRI scan" on page 20.
Full-body eligible – Preparing the patient before the MRI scan
Warnings:
- Do not perform an MRI scan if the patient's body temperature is above 38°C (100°F). Do not use blankets or heated blankets. Elevated body temperature combined with tissue heating from the MRI scan increases the risk of excessive tissue heating and damage.
- Position patients only in prone or supine positions. Scanning in other positions is untested and may cause excessive tissue heating.
- Monitor continuous scan time and wait time. A maximum of 30 minutes of continuous scan time is allowed, followed by a 5-minute wait time. Exceeding these limits increases the risk of tissue heating.
Table 5. Full-body eligible – Preparing the patient before the MRI scan
Ensure that MRI mode is activated. | The text and symbols indicate full-body MRI scan eligibility and that the system is in MRI mode. MR ☍ ⓘ MR Conditional Full Body Scan Eligible |
Check core body temperature. | Confirm the patient's body temperature is ≤38 °C (100 °F). Do not use blankets. |
Patient position | Position the patient in a prone or supine position in the MRI bore. |
Notes:
- If possible, do not sedate the patient to allow for feedback during the examination.
- Inform the patient of all risks associated with the MRI examination as stated in this section.
- Monitor the patient during the MRI examination.
After confirming these conditions, proceed to "Full-body eligible – During the MRI scan" on page 21.
Full-body eligible – During the MRI scan
- Monitor continuous scan time and wait time (max 30 minutes continuous, 5 minutes wait).
- Verify the patient is feeling normal and responsive between scan sequences.
- Discontinue the MRI immediately if the patient experiences heating, pain, shocking sensations, uncomfortable stimulation, or unusual sensations.
After the scan, proceed to "Full-body eligible – Post-MRI scan" on page 21.
Full-body eligible – Post-MRI scan
Cautions:
- MRI may affect neurostimulator operation or reset parameters to power-on-reset (POR). Reprogramming with the clinician app or programmer may be necessary. If the patient control device cannot synchronize, turn therapy on, or displays "POR", instruct the patient to see the managing clinician.
- Failure to return to normal therapy settings after the MRI scan may result in symptom recurrence.
Table 6. Full-body eligible – Post MRI scan
Turn therapy back on | After the scan, instruct the patient (outside the scanner room) to turn therapy back on. From the MRI Eligibility screen, ask the patient to place the communicator over the device and tap DEACTIVATE when prompted to deactivate MRI mode, then tap YES to return to previous therapy settings. |
Notes:
- Verify the patient has not experienced adverse effects. Contact Medtronic to report any adverse effects.
- Instruct the patient to see the implanting or managing physician if: they have questions about neurostimulator function, assistance is needed to return program parameters to pre-MRI settings, or the patient control device displays a power-on-reset (POR) screen.
Head-only Eligible MRI Scan Conditions
MR Conditional Head Scan Eligible with Transmit/Receive Head Coil
Confirm via the "Head-only eligible – Handset identification" section that a head-only scan is appropriate. Patients identified as head-only eligible can have 1.5-T MRI scans of the head using a Detachable Head Transmit/Receive Volume Coil, in addition to other specified conditions.
Head-only eligible – Handset Identification
1. What type of patient control device did the patient bring?
Patient control device A with MRI icon:
- The text and symbols indicate head-only MRI scan eligibility and that the system is in MRI mode.
MR ☍ ⓘ MR Conditional Head Scan Eligible with Transmit/Receive Head Coil - Proceed with head-only eligible Table 7 (page 24) for Model 97800 and Model 3058, or Table 8 (page 25) for Model 3023.
Patient control device A without MRI icon:
- Confirm eligible neurostimulator model number on the patient control device screen. See Appendix A "Part 2. Patient Control Device A without MRI icon: Stopping Therapy" on page 30.
- Turn therapy off before scanning.
- Proceed with head-only eligible Table 7 (page 24) for Model 3058, or Table 8 (page 25) for Model 3023.
Patient control device B:
- Confirm eligible neurostimulator model number on the patient control device screen. See "Appendix B: Patient Control Device B Instructions" on page 32.
- Turn therapy off before scanning.
- Proceed with head-only eligible Table 7 (page 24) for Model 3058, or Table 8 (page 25) for Model 3023.
Head-only eligible – MRI Equipment and Scan Requirements
Warning: Scans must adhere to the MRI equipment, scan, and RF field requirements specified in the head-only section of this manual. Failure to comply may result in patient discomfort, device damage, or serious/permanent patient injury due to excessive heating or other risks.
General MRI Conditions:
- Identify scan-type eligibility using the patient control device. Do not proceed without eligibility confirmation.
- Activate MRI mode using patient control device A with MRI. If using patient control device A without MRI icon or patient control device B, turn therapy off.
Cautions:
- Model 3023 neurostimulator only: Do not conduct an MRI scan if the serial number is ineligible for MRI. To avoid increased risk of damage, patients with the following serial numbers should not have MRI scans: Less than NBV132955H, Between NBV133037H and NBV133063H, Between NBV628045S and NBV628263S.
- Model 3023 neurostimulator only: Do not conduct an MRI scan if the patient can use a control magnet to turn the neurostimulator on or off, unless a clinician has first disabled the magnet switch. Failure to disable the switch could result in uncomfortable, unintended stimulation.
- Model 3023 neurostimulator only: Control magnet function after MRI: Do not conduct an MRI scan if the patient can only use a control magnet. An MRI scan may permanently damage the magnet switch. If damaged, the patient will require a patient control device to turn the neurostimulator on or off.
Table 7. Model 97800 and Model 3058 head-only eligible conditions – 1.5-T MRI equipment and scan requirements
MRI scanner | |
---|---|
Confirm the neurostimulator model number on the patient control device. [Select one:] | |
Confirm that MRI mode is activated or therapy is off. [Select one:] | |
MRI system type | |
Maximum gradient slew rate specification | ≤ 200 T/m/s per axis |
Maximum spatial field gradient | 20 T/m (2000 gauss/cm) |
RF coil type | |
RF exposure level | Normal Operating Mode |
Note: When implanted per approved indications, InterStim system components are outside of the head coil.
Proceed to "Head-only eligible – Preparing the patient before the MRI scan" on page 26. If the patient has a Model 3023 neurostimulator, see Table 8 on page 25.
Table 8. Model 3023 head-only eligible conditions – 1.5-T MRI equipment and scan requirements
MRI scanner | |
---|---|
Confirm the neurostimulator model number. | Check ineligible serial numbers for the Model 3023 neurostimulator in Table 1 on page 8. |
Confirm patient cannot use a control magnet. | Do not conduct an MRI scan if the patient can use a control magnet to turn the neurostimulator on or off, unless a clinician has first disabled the magnet switch. |
Confirm that MRI mode is activated or therapy is off. [Select one:] | |
MRI system type | |
Maximum gradient slew rate specification | ≤ 200 T/m/s per axis |
Maximum spatial field gradient | 20 T/m (2000 gauss/cm) |
RF coil type | |
RF exposure level | Normal Operating Mode |
Note: When implanted per approved indications, InterStim system components are outside of the head coil.
Proceed to "Head-only eligible – Preparing the patient before the MRI scan" on page 26.
Head-only eligible – Preparing the patient before the MRI scan
- Ensure MRI mode is activated or therapy is off.
- If possible, do not sedate the patient to allow for feedback during the examination.
- Inform the patient of all risks associated with the MRI examination as stated in this section.
- Monitor the patient during the MRI examination.
Head-only eligible – During the MRI scan
- Monitor the patient visually and audibly. Verify the patient is feeling normal and responsive between scan sequences.
- Discontinue the MRI immediately if the patient experiences heating, pain, shocking sensations, uncomfortable stimulation, or unusual sensations.
Head-only eligible – Post-MRI scan
Cautions:
- MRI may affect neurostimulator operation or reset parameters to power-on-reset (POR). Reprogramming with the clinician app or programmer may be necessary. If the patient control device cannot synchronize, turn therapy on, or displays "POR", instruct the patient to see the managing clinician.
- Failure to return to normal therapy settings after the MRI scan may result in symptom recurrence.
Table 9. Head-only eligible – Post MRI scan
Turn therapy back on. [Select one:] | |
---|---|
After the scan, instruct the patient (outside the scanner room) to turn therapy back on using patient control device A or B. For patient control device A with ☍ MRI: From the MRI Eligibility screen, ask the patient to place the communicator over the device and tap DEACTIVATE when prompted to deactivate MRI mode, then tap YES to return to previous therapy settings. For patient control device A without MRI icon: Ask the patient to turn therapy on. 1. Place the communicator over the implanted neurostimulator site. 2. On the patient therapy app Home screen, swipe the On/Off Switch from Off to On. For patient control device B: Ask the patient to press the Sync ⚙️ key. Then the patient can use normal procedures to turn therapy back on. |
Notes:
- Verify the patient has not experienced adverse effects. Contact Medtronic to report any adverse effects.
- Instruct the patient to see the implanting or managing physician if: they have questions about neurostimulator function, assistance is needed to return program parameters to pre-MRI settings, or the patient control device displays a power-on-reset (POR) screen.
Appendix A: Patient Control Device A Instructions
HH90 Handset Instructions
Use these instructions to guide the patient in using patient control device A (HH90 Handset and TM90 Communicator) to prepare the system for the MRI scan.
Part 1. Patient Control Device A with MRI icon: Activating MRI Mode
If MR appears on patient control device A, use the handset to place InterStim systems in MRI mode before an MRI scan. Ensure you are outside the MRI scanner room. Scan Eligibility icons will appear.
Note: During the MRI scan, keep the InterStim system in MRI mode. Do not deactivate MRI mode. Therapy must remain off.
- Press ☍ on the communicator to turn it on. The communicator will attempt to connect to the handset but cannot until the patient therapy app is launched. The blue LED light blinks to indicate it is on and in discovery mode.
- Open the patient therapy app on the handset to initiate the connection.
- Once the communicator connects to the handset, the blue LED light will be solid. Place the communicator over the neurostimulator implant area and tap FIND DEVICE on the handset.
Note: If the communicator fails to connect, readjust its position over the neurostimulator and tap RETRY.
- Once the communicator successfully connects to the implanted neurostimulator, you will be taken to the patient therapy app Home screen.
- Tap ☰ in the corner of the patient therapy app Home screen and select MRI.
Note: If the handset screen says "Not Ready for MRI Scan" and "Not Eligible", STOP. The neurostimulator is not eligible for MRI scans, and MRI mode is unavailable. Do not scan. Contact clinician.
- Tap ACTIVATE to activate MRI mode. (Activating MRI mode stops therapy.)
- Determine the message on the MRI eligibility screen:
- MR Conditional Full Body Scan Eligible
- MR Conditional Head Scan Eligible with Transmit/Receive Head Coil
- MRI eligibility cannot be determined
Note: If the handset screen says "MRI eligibility cannot be determined", STOP. Further clinician assessment is required. Contact clinician before scanning.
- Return to Step 2 on page 14 in the ELIGIBILITY IDENTIFICATION section and follow instructions for the images and text on patient control device A with ☍ MRI.
Note: If the patient has patient control device A without the MRI icon, proceed to "Part 2. Patient Control Device A without MRI icon: Stopping Therapy" on page 30.
Part 2. Patient Control Device A without MRI icon: Stopping Therapy
If the patient has patient control device A without the MRI icon, use the handset to stop therapy to prepare the neurostimulator for the MRI scan. Ensure you are outside the MRI scanner room.
Note: During the MRI scan, keep the InterStim system off. Therapy must remain off.
- Press ☍ on the communicator to turn it on. The communicator will attempt to connect to the handset but cannot until the patient therapy app is launched. The blue LED light blinks to indicate it is on and in discovery mode.
- Open the patient therapy app on the handset to initiate the connection.
- Once the communicator connects to the handset, the blue LED light will be solid. Place the communicator over the neurostimulator implant area and tap FIND DEVICE on the handset.
Note: If the communicator fails to connect, readjust its position over the neurostimulator and tap RETRY.
- Once the communicator successfully connects to the implanted neurostimulator, you will be taken to the patient therapy app Home screen where you can turn off therapy (turn off the neurostimulator).
Confirm the neurostimulator model number and serial number:
- Tap ☰ in the corner of the screen on the handset, and select About.
- Tap the Device tab for details about the model and serial number.
- For a Model 3058 neurostimulator: All serial numbers are MR Conditional Head Scan Eligible with Transmit/Receive Head Coil.
- For a Model 3023 neurostimulator: Check the serial number to confirm that the Model 3023 neurostimulator is MR Conditional Head Scan Eligible with Transmit/Receive Head Coil.
Turn therapy off:
- First, place the communicator over the implanted neurostimulator site.
- Then, on the patient therapy app Home screen, swipe the On/Off Switch from On to Off.
- Confirm by tapping OK.
Proceed with head-only eligible Table 7 for Model 3058 on page 24 or Table 8 for Model 3023 on page 25.
Cautions:
- Model 3023 neurostimulator only: Do not conduct an MRI scan if the serial number is ineligible for MRI. To avoid increased risk of neurostimulator damage, patients with the following serial numbers should not have MRI scans: Less than NBV132955H, Between NBV133037H and NBV133063H, Between NBV628045S and NBV628263S.
- Model 3023 neurostimulator only: Do not conduct an MRI scan if the patient can use a control magnet to turn the neurostimulator on or off, unless a clinician has first disabled the magnet switch. Failure to disable the magnet switch could result in uncomfortable, unintended stimulation during the MRI examination.
- Model 3023 neurostimulator only: Control magnet function after MRI: Do not conduct an MRI scan if the patient can only use a control magnet. An MRI scan may permanently damage the magnet switch in the neurostimulator. If the magnet switch is damaged, the patient will require a patient control device to turn the neurostimulator on or off.
Appendix B: Patient Control Device B Instructions
Model 3037 Patient Programmer Instructions
Use these instructions to guide the patient in using patient control device B (InterStim iCon Model 3037 Patient Programmer) to display the screen showing the neurostimulator model (IM) or serial number (IS) and to turn therapy off for the MRI scan.
Stopping Therapy for MRI
- Synchronize the patient control device and neurostimulator. Hold the programmer over the neurostimulator and press the Sync ⚙️ key.
Note: A suspected EOS (End of Service) neurostimulator requires MRI eligibility confirmation from a clinician. See "MRI Scan-Type Eligibility Form" near the back of this manual.
- Using the patient's Model 3037 Patient Programmer, press the Up arrow on the Navigator key.
- Press the Left arrow on the Navigator key once to select information screens.
- Press the Down arrow on the Navigator key.
- Press the Left or Right arrows on the Navigator key to scroll through each information screen to find the model number (Figure 4, left).
For a Model 3023 neurostimulator, check the serial number (IS) by pressing the Left or Right arrows until the IS screen appears (Figure 4, right). Consult Table 1 on page 8 to confirm that the Model 3023 neurostimulator is MR Conditional Head Scan Eligible with Transmit/Receive Head Coil.
Figure 4. Neurostimulator model (IM) (left) and serial number (IS) (right) screens.
- After confirming whether the neurostimulator is head-scan eligible, hold the programmer over the neurostimulator and press the Neurostimulator off ☍ key.
- If the neurostimulator is head-scan eligible, proceed with head-only eligible Table 7 for Model 3058 on page 24 or Table 8 for Model 3023 on page 25.
Cautions:
- Model 3023 neurostimulator only: Do not conduct an MRI scan if the serial number is ineligible for MRI. To avoid increased risk of neurostimulator damage, patients with the following serial numbers should not have MRI scans: Less than NBV132955H, Between NBV133037H and NBV133063H, Between NBV628045S and NBV628263S.
- Model 3023 neurostimulator only: Do not conduct an MRI scan if the patient can use a control magnet to turn the neurostimulator on or off, unless a clinician has first disabled the magnet switch. Failure to disable the magnet switch could result in uncomfortable, unintended stimulation during the MRI examination.
- Model 3023 neurostimulator only: Control magnet function after MRI: Do not conduct an MRI scan if the patient can only use a control magnet. An MRI scan may permanently damage the magnet switch in the neurostimulator. If the magnet switch is damaged, the patient will require a patient control device to turn the neurostimulator on or off.
Appendix C: X-ray Identification – InterStim Systems
X-ray identification allows determination of the manufacturer and InterStim neurostimulator model number using standard X-ray procedures. The Medtronic symbol ✔ identifies Medtronic. To identify the lead, use X-ray imaging and look for a transition in lead body diameter size near the lead electrodes. In an InterStim SureScan MRI lead, the braided part of the lead body has a wider radiographic diameter than the lead body at the lead-electrode (distal) end. See Table 10.
InterStim System X-ray Identification
Table 10. Neurostimulator ID code and X-ray identification of the lead
INS radiopaque ID code | X-ray identification of the lead |
---|---|
NMF | Full-body MR Conditional with InterStim SureScan MRI lead Model 978A1XX (See Note below.) ① Lead body with braiding ② Lead body radiographic diameter transition near distal end |
ID code NMF – Model 97810 InterStim Micro rechargeable neurostimulator | |
ANJY | Full-body MR Conditional with InterStim SureScan MRI lead Model 978B1XX (See Note below.) ① Lead body with braiding ② Lead body radiographic diameter transition near distal end |
ID code NJY – Model 97800 InterStim X neurostimulator OR Model 3058 InterStim II neurostimulator | |
Head-scan MR Conditional with Detachable Head Transmit/Receive Volume Coil with lead Model 3093 (1) |
|
Head-scan MR Conditional with Detachable Head Transmit/Receive Volume Coil with lead Model 3889 1 |
|
1 Lead body without braiding | |
NBV | If eligible, head-scan MR Conditional with Detachable Head Transmit/Receive Volume Coil with any InterStim lead model |
ID code NBV – Model 3023 InterStim neurostimulator No MRI scans if the Model 3023 serial number is: Less than NBV132955H Between NBV133037H and NBV133063H Between NBV628045S and NBV628263S |
|
Model 7427T is not eligible for MRI scans. | |
(2) | 1. Neurostimulator Connector Block 2. NFE |
ID code NFE – Model 7427T InterStim Twin Neurostimulator |
Note: "XX" in 978A1XX and 978B1XX in labeling refers to the lead length. Wherever 978A1 and 978B1 are used, this refers to all lead lengths.
Appendix D: MRI Scan-Type Eligibility Form
Medtronic Neurostimulation System MRI Scan-Type Eligibility Form
At the time of the MRI appointment:
- See labeling for MRI scan conditions: www.medtronic.com/mri.
- Using the patient control device, confirm that MRI mode is activated (HH90 Handset and TM90 Communicator) or therapy is off (InterStim iCon Model 3037 Patient Programmer) prior to the MRI scan.
Patient name: | ||
---|---|---|
Physician name, office, address, and phone number: | ||
Date and time eligibility was determined: | Neurostimulator model number: | Neurostimulator serial number: |
MR Conditional Full Body Scan Eligible | ||
MR Conditional Head Scan Eligible with Transmit/Receive Head Coil | ||
The neurostimulation system MRI scan-type eligibility cannot be determined. |
Important: Use the clinician or patient control device to determine scan eligibility and enter the information below.
Information code:
File Info : application/pdf, 38 Pages, 3.66MB
DocumentDocumentReferences
Health tech for the digital age | Medtronic
Medtronic MRI Resource Library: Region
Global Healthcare Technology Leader | Medtronic
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