St Jude Medical Product Catalog

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Diante Scharsch

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Aug 3, 2024, 11:42:29 AM8/3/24

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For an MR Conditional system, all implanted components must be approved MR Conditional models and implanted in approved locations according to the above image. If the implanted system contains any other components or models, then the system is considered MR Unsafe. In addition, a component must be implanted according to its approved location or the entire implanted system is considered MR Unsafe.

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.

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.

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.

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.

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 37C (98.6F). 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.

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.

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.

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.

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