MR Conditional SCS/DRG Systems

The following warnings, precautions, and potential adverse events apply when performing MRI scans on Abbott MR Conditional SCS/DRG systems.

Warnings

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

• Upgrade their patient controller to the latest Patient Controller app from the app store.
• Disable automatic updates for the patient controller app and the device operating system software (such as Apple^‡ iOS^‡).
• Do not enable MRI Mode more than 24 hours prior to the MRI scan. 

While in MRI Mode

• Do not alter, damage, update or lose their patient controller while in MRI Mode.
• Do not update, install or delete the patient controller app while in MRI Mode.
• Do not delete the pairing between the IPG and the patient controller or delete the IPG from the Generators list while in MRI Mode.
• Do not update the device operating system 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.

Precautions

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.

Potential Adverse Events

• 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

MR Conditional DBS Systems

The following warnings, precautions and potential adverse events apply when performing MRI scans on Abbott MR Conditional DBS systems. 

Warnings

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

• Upgrade their patient controller to the latest Patient Controller app from the app store.
• Disable automatic updates for the patient controller app and the device operating system software (such as Apple^‡ iOS^‡).
• Do not enable MRI Mode more than 24 hours prior to the MRI scan. 

While in MRI Mode

• Do not alter, damage, update or lose their patient controller while in MRI Mode.
• Do not update, install or delete the patient controller app while in MRI Mode.
• Do not delete the pairing between the IPG and the patient controller or delete the IPG from the Generators list while in MRI Mode.
• Do not update the device operating system 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.

Precautions

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.

Potential Adverse Events

• 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

24-88167 MAT-2305130 v3.0 | Item approved for U.S. use only.