For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the MRI Procedure Information for the patient's implanted device.
For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the MRI Procedure Information for the patient's implanted device.
We know that MRI images are used as a tool to visualize diagnostic imaging and help provide information that may be useful to a clinician. That's why we’ve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Certain Abbott neurostimulation systems are MR Conditional with 1.5T closed bore scanners subject to conditions in the MRI Procedures Manual.
Before your patient undergoes an MRI scan:
Confirm the MR Conditional components and location of the system (this information is included on the Abbott Patient ID card).
Confirm that no adverse conditions to MR scanning are present.
Ensure the patient’s neurostimulation system is in MRI mode.
Review the general scan requirements.
Confirm specific scan requirements for the patient's system, intended scan location, and RF coil type.
Note, the Class I recall on the Proclaim™ Family of devices and the Infinity™ DBS System initiated in July 2023 does not impact a patient's eligibility for receiving an MRI scan, the conditions for the MRI eligibililty, or the patient safety in an MRI environment. See product advisories.
For expanded patient instructions on how to prepare for an MRI scan, please see the links below:
We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Learn more about the scan details for our MR Conditional products below.
WARNING: For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. If the implanted system contains components or models not listed in the following table, then the system is considered MR Unsafe. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MR Unsafe.
Please select 'Scan Details' in the table below to view specific scan requirements.
| Generator | Lead Type | Length | Location | Details |
|---|---|---|---|---|
Eterna™ SCS System (model 32400) | Octrode™ stimulation lead (model 3186)
Octrode™ stimulation lead (model 3189)
Penta™ 5-column paddle lead (model 3228)
TriCentrus™ 3-column paddle lead (model 3292) | 60 cm
90cm
60cm
60cm
| IPG: upper buttock, low back, midback, flank or abdomen Lead tip: between C1 and S2 | Scan Details |
Proclaim™ Plus or Proclaim™ XR SCS System (models 3670, 3672, 3660, 3662) | Octrode™ stimulation lead (model 3186)
Penta™ 5-column paddle lead (model 3228) | 60 cm | IPG: upper buttock, low back, midline, flank or abdomen Lead tip: between C1 and S2
IPG: upper buttock, low back, midline, flank or abdomen Lead tip: between T7 and T12 |
|
Protégé™ or Prodigy™ MRI IPG (models 3771, 3772) | Octrode™ stimulation lead (model 3186) or Penta™ 5-column paddle lead (model 3228) | 60 cm | IPG: upper buttock, low back, midline, flank or abdomen Lead tip: between T7 and T12 | Scan Details |
Proclaim™ DRG Neurostimulation System (model 3664) | SlimTip™ Implant Lead (model MN10450-50A) or model MN10450-50 | 50 cm | IPG: Upper buttock, low back, flank, or abdomen Lead tip: between T10 and S2 | Scan Details |
Abbott offers two types of MR Conditional, fully implanted DBS configurations:
WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered unsafe for an MRI environment.
All components listed must be implanted unless noted as "optional." Up to two leads, lead protection boots, and burr hole covers may be implanted. See Full System Components below if the patient has an IPG and extensions implanted.
For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual.
Approved models and implant locations for an MR Conditional lead-only system
| Component | Model | Location | |
|---|---|---|---|
| Lead | 6170 directional lead, 30 cm, 0.5-mm spacing, black 6171 directional lead, 30 cm, 1.5-mm spacing, black 6172 directional lead, 40 cm, 0.5-mm spacing, black 6173 directional lead, 40 cm, 1.5-mm spacing, black | • Fully implanted in the brain, routed under the scalp • Must be connected to a lead protection boot | Scan Details |
| Lead protection boot | Included in lead kit | • Fully implanted under the skin • Must be connected to a lead | |
| Burr hole cover (optional) | 6010 Guardian™ cranial burr hole cover system | Head |
All components listed must be implanted unless noted as "optional." Up to two IPGs, leads, extensions, and burr hole covers may be implanted.
For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual.
Approved models and implant locations for an MR Conditional full system
| Component | Model | Location | |
|---|---|---|---|
| IPG* | 6660 Infinity 5 IPG 6662 Infinity 7 IPG | • Pectoral • Abdomen | Scan Details |
| Lead | 6170 directional lead, 30 cm, 0.5-mm spacing, black 6171 directional lead, 30 cm, 1.5-mm spacing, black 6172 directional lead, 40 cm, 0.5-mm spacing, black 6173 directional lead, 40 cm, 1.5-mm spacing, black | • Fully implanted in the brain, routed under the scalp and connected to an extension • May cross the head's midline | |
| Extension | 6371 flexible extension, 50 cm 6372 flexible extension, 60 cm | Head and neck, routed to the IPG on the same side of the body as the IPG | |
| Burr hole cover (optional) | 6010 Guardian™ cranial burr hole cover system | Head |
*The IPG port plug associated with these models is also an MR Conditional component
The following warnings, precautions, and potential adverse events apply when performing MRI scans on Abbott MR Conditional SCS/DRG systems.
Unapproved components. Do not perform an MRI scan on patients who have any components of a neurostimulation system that are unapproved for use in an MR environment. Serious patient injury could occur.
Abandoned devices. Do not perform an MRI scan on patients who have an incomplete neurostimulation system, where a lead is present without the IPG or disconnected from the system. Serious patient injury could occur.
Nonfunctional leads. Do not perform an MRI scan on patients when the “MRI is Not Advised. There may be a problem with the implanted lead(s)” message displays when attempting to enter MRI mode on the patient controller. MRI scans of nonfunctional leads may result in excessive heating occurring at the location of the implanted lead electrodes and serious patient injury.
Location of implanted system. To meet the MR Conditional requirements, components must be implanted according to the approved locations specified by the MRI labeling. The MR Conditional leads must be implanted in the epidural space and routed subcutaneously to the IPG pocket. Two leads should travel in close proximity to one another from the IPG to the spine. Lead tips can be located at different spinal epidural levels. MRI scans of implants that are not located in approved locations can possibly result in increased unintended stimulation, excessive heating at the lead electrodes, and serious patient injury.
Location of RF transmit-receive coils [Select systems only, refer to the MR Procedure Information to determine applicability]. Head or extremity MRI scans can be conducted safely using a Detachable Head or Extremity RF transmit-receive coil when no parts of the implanted neurostimulation system are within the transmit-receive coil according to the conditions specified for each system in the MRI labeling. This can be confirmed with X-ray imaging of the neck, head, and extremity regions or by referring to the patient records.
Skin erosion. Do not perform an MRI scan on patients who have any portion of their implanted system exposed due to skin erosion. The MRI scan may result in excessive heating of the system and serious patient injury.
Neurostimulation trial systems. Do not perform an MRI scan on patients who have an external neurostimulation trial system or any components that are not fully implanted. Serious patient injury could occur.
Multiple neurostimulation systems. Do not perform an MRI scan on patients who have multiple MR Conditional neurostimulation systems for pain (multiple IPGs for pain). MRI scans may result in excessive heating of the lead electrodes and serious patient injury.
Other implanted medical devices. Prior to an MRI examination, determine whether the patient has multiple medical device implants, either active medical device implants (such as deep brain stimulation systems, implantable cardiac defibrillators, pacemakers) or passive medical device implants (such as spinal hardware, stents). Of all medical device implants, the most restrictive MRI exposure requirements must be used. Do not conduct an MRI scan if any conditions or implants prohibit it, as serious patient injury could occur. If you are unclear what implants are present, perform an X‑ray to determine the implant type and location.
Imaging with atoms other than hydrogen. Do not conduct MRI scans with nonproton scanning frequencies (such as 13C, 23Na, or 31P). Frequencies other than 64 MHz could cause device damage, excessive heating, and serious patient injury.
MRI system type. Only use 1.5T cylindrical-bore magnet, horizontal field-orientation MRI systems. Do not scan with other MRI systems, such as 1.0T and 3.0T machines or vertical field orientation machines, as device damage, excessive heating of implanted components, and serious patient injury could occur.
Patient position. Do not scan with the patient in any prone positions or “superman” positions (where the patient's arm is raised above his or her head). Use of these positions could cause device damage and excessive heating of implanted components, which could result in serious patient injury.
Operating mode. Do not conduct MRI scans in first-level controlled or second-level controlled operating mode. These modes allow higher levels of RF energy and may cause excessive heating of implanted components, which could result in serious patient injury.
SAR or B1+rms limits. For scans requiring maximum SAR <2 W/kg or specific maximum B1+rms value, personnel knowledgeable in MR safety should be involved to optimally plan the scan and actively monitor SAR or B1+rms levels during the scan. Ensure the scanner displays the SAR or B1+rms value prior to starting the scan. Exceeding the SAR or B1+rms limits may cause excessive heating of implanted components, which could result in serious patient injury.
Transmit coils. Only use circularly polarized transmit coil designs. Do not scan with other transmit coil designs (for example, linear, phased-array, or saddle) as serious patient injury could occur.
Active scan time. The total active scan time must be limited to 30 minutes per session with a wait time of 30 minutes between sessions. Exceeding the active scan time limit increases the risk of excessive heating and serious patient injury.
Fever. Before an MRI scan, determine the patient's body temperature. If the patient has a fever, do not perform an MRI scan. The MR Conditional evaluation has been performed for patients with a typical body temperature of 37°C (98.6°F). Elevated body temperature in conjunction with tissue heating caused by the MRI scan could result in excessive heating of implanted components and serious patient injury.
MRI Mode patient instructions. For Proclaim™ spinal cord stimulation (SCS) and dorsal root ganglion (DRG) systems, a paired patient controller or clinician programmer is required to disable MRI Mode. The inability to disable MRI Mode would require device replacement surgery to restore therapy. Provide the following instructions to patients with a Proclaim™ SCS or DRG system.
Prior to enabling MRI Mode
While in MRI Mode
Disabling MRI Mode. For Proclaim™ spinal cord stimulation (SCS) and dorsal root ganglion (DRG) systems, an inability to disable MRI Mode will occur if the patient controller is no longer paired to the IPG and there is no previously paired clinician programmer available or if the clinician programmer lost its pairing to the IPG. The inability to disable MRI Mode would require device replacement surgery to restore therapy.
External devices. Do not allow external control devices into the scanner magnet room, such as a programmer, controller or charging system. Because these devices contain ferromagnetic material, they can be affected by the MRI magnet, may present a projectile hazard and are considered MR Unsafe.
Electromagnetic interference (EMI). Some electrical equipment, such as an MRI machine, may generate enough EMI to interfere with the operation of the internal or external electronic components of a neurostimulation system if the equipment is too close to the system component. To mitigate the effects of possible EMI, increase the distance between the electrical equipment and the system component that is affected and try performing the operation again.
Lead electrode heating resulting in patient discomfort, tissue damage or serious patient injury
IPG heating resulting in tissue damage in the implant pocket or patient discomfort or both
Induced currents on leads resulting in overstimulation or shocking sensations
Damage to the IPG or leads causing the system to fail to deliver stimulation or causing the system to deliver overstimulation
Damage to the functionality or mechanical integrity of the IPG resulting in the inability to communicate with the IPG
Movement or vibration of the IPG or leads
The following warnings, precautions and potential adverse events apply when performing MRI scans on Abbott MR Conditional DBS systems.
Unapproved components. Do not perform an MRI scan on patients who have any components of a neurostimulation system that are unapproved for use in an MR environment. Serious patient injury could occur.
Abandoned devices. Do not perform an MRI scan on patients who have any abandoned neurostimulation devices, such as an implantable pulse generator (IPG), lead, extension or adapter. Serious patient injury could occur.
Nonfunctional leads or extensions. Do not perform an MRI scan on patients with broken or intermittent MR Conditional leads or extensions, or impedance measurements not within the impedance limits. MRI scans of nonfunctional leads may result in excessive heating occurring at the location of the implanted lead electrodes and serious patient injury.
Location of implanted system. To meet the MR Conditional requirements, components must be implanted according to the approved locations specified by the MRI labeling. Implant location can be confirmed with X-ray imaging or by referring to the patient records. The MR Conditional leads and extensions must be fully implanted under the skin and routed on the same side of the body as the IPG pocket.
Routing multiple leads and extensions to the same IPG. If multiple MR Conditional leads and extensions are routed to the same IPG, they should be routed in close proximity on the same side of the body as the IPG. Nonadjacent leads and extensions can result in increased unintended stimulation or heating at the lead electrodes.
Partially implanted or exposed components. Do not perform an MRI scan on patients who have any portion of their system exposed due to partial implantation or skin erosion. The MRI scan may cause heating of the system, which could result in serious patient injury.
Multiple neurostimulation systems. If a patient is implanted with two DBS IPGs, ensure that both IPGs are set to MRI mode before scanning. If a patient is implanted with one lead-only system and one full system, follow the more restrictive MRI scanning requirements of the systems, and ensure that the IPG is set to MRI mode before scanning.
Other implanted medical devices. Scanning patients who have other MR Conditional devices is acceptable as long as all the MR Conditional requirements for each of the implanted devices are met. Do not conduct an MRI scan if any conditions or implants prohibit it. If you are unclear what implants are present, perform an X‑ray to determine the implant type and location.
Imaging with atoms other than hydrogen. Imaging with atoms other than hydrogen has not been tested and could result in serious patient injury.
Patient body temperature. Before an MRI scan, determine the patient's body temperature. If the patient has a fever, you should not perform an MRI scan.
MRI Mode patient instructions. For Infinity™ deep brain stimulation (DBS) systems, a paired patient controller or clinician programmer is required to disable MRI Mode. The inability to disable MRI Mode would require device replacement surgery to restore therapy. Provide the following instructions to patients with an Infinity™ deep brain stimulation (DBS) system.
Prior to enabling MRI Mode
While in MRI Mode
Disabling MRI Mode. For Infinity™ deep brain stimulation (DBS) systems, an inability to disable MRI Mode will occur if the patient controller is no longer paired to the IPG and there is no previously paired clinician programmer available or if the clinician programmer lost its pairing to the IPG. The inability to disable MRI Mode would require device replacement surgery to restore therapy.
External devices. Do not allow external control devices into the scanner magnet room, such as a programmer, controller, or charging system. Because these devices contain ferromagnetic material, they can be affected by the MRI magnet, may present a projectile hazard, and are considered MR Unsafe.
Electromagnetic interference (EMI). Some electrical equipment, such as an MRI machine, may generate enough EMI to interfere with the operation of the internal or external electronic components of a neurostimulation system if the equipment is too close to the system component. To mitigate the effects of possible EMI, increase the distance between the electrical equipment and the system component that is affected and try performing the operation again.
Turning off stimulation before a scan. When you set a full system into MRI mode, stimulation turns off. Carefully consider a patient’s underlying medical condition and disease symptoms before turning off a neurostimulation system when performing an MRI scan. Consult with the appropriate medical professional, such as a patient’s DBS managing clinician, to determine if it is safe to turn off stimulation to conduct an MRI scan. Do not conduct an MRI scan if stimulation needs to stay on.
Lead electrode heating resulting in tissue damage or serious patient injury
IPG heating resulting in tissue damage in the implant pocket or patient discomfort or both
Induced currents on leads resulting in unpleasant sensations or motor disturbances
Damage to the IPGs, leads or extensions causing the system to fail to deliver stimulation or causing the system to deliver overstimulation
Damage to the functionality or mechanical integrity of the IPG resulting in the inability to communicate with the IPG
Movement or vibration of the IPGs, leads or extensions
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