Evera MRI SureScan
Model DDMB2D4 | Medtronic, Inc. | ICD
Models with the same MRI conditions
DDMB1D1, DDMB1D4, DDMB2D1, DDMB2D4, DDMC3D1, DDMC3D4, DVMB1D1, DVMB1D4, DVMB2D1, DVMB2D4, DVMC3D1, DVMC3D4
The MRI conditions shown are based on the manufacturer's official guidelines.
Do not apply them to models not listed above; search for that model separately. Search models →
MR Conditional
Important alert
- Do not scan patients who do not have a complete MRI SureScan defibrillation system.
- Do not scan patients with lead extenders or lead adaptors. Do not scan patients with broken, abandoned, or intermittent leads.
- Do not scan patients with a SureScan defibrillation system implanted in sites other than the left and right pectoral region.
- Confirm lead compatibility with cardiology or the pacemaker clinic.
1Pre-scan checks
- A complete SureScan defibrillation system includes an Evera MRI SureScan DR ICD device with a SureScan right atrial pacing lead and a SureScan defibrillation lead, or an Evera MRI SureScan VR ICD with a SureScan defibrillation lead.
- The patient has no implanted lead extenders, lead adaptors, or abandoned leads.
- The patient has no broken leads or leads with intermittent electrical contact.
- The SureScan defibrillation system is implanted in the left or the right pectoral region.
- Do not scan a patient without first programming the MRI SureScan mode to On.
2MRI scan conditions
1.5 T
| Scanner type | Horizontal field, cylindrical bore, clinical system for hydrogen proton imaging |
|---|---|
| Spatial gradient | Maximum spatial gradient of ≤ 20 T/m (2000 gauss/cm) |
| Gradient slew rate | Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 T/m/s |
| Operating mode | MRI radio frequency (RF) power – Normal Operating Mode |
| Whole-body SAR | The whole body averaged specific absorption rate (SAR) must be ≤ 2.0 W/kg. |
| Head SAR | The head SAR must be ≤ 3.2 W/kg. |
3.0 T
| Scanner type | Horizontal field, cylindrical bore, clinical system for hydrogen proton imaging |
|---|---|
| Spatial gradient | Maximum spatial gradient of ≤ 20 T/m (2000 gauss/cm) |
| Gradient slew rate | Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 T/m/s |
| Operating mode | MRI radio frequency (RF) power – First Level Controlled Operating Mode or Normal Operating Mode |
| B1+rms | • B1+RMS must be ≤ 2.8 µT when the isocenter (center of the MRI bore) is inferior to the C7 vertebra.• Scans can be performed without B1+RMS restriction when the isocenter is at or superior to the C7 vertebra (see Figure 1). [p. 5] |
3RF COIL / RF excitation
| RF coil | Use of transmit/receive and receive-only coils – There are no restrictions on the use of local transmit/receive coils for MRI scanning of the head or of the extremities, and there are no restrictions on the placement of receive-only coils. |
|---|
4Monitoring & emergency response
- While the MRI SureScan mode is programmed to On, tachyarrhythmia detection and therapy are suspended, leaving the patient at risk of death from untreated spontaneous tachyarrhythmia. Therefore, proper patient monitoring is required during the entire time when the MRI SureScan mode is programmed to On.
- Continuous monitoring of the patient’s heart rate using instrumentation such as pulse oximetry (plethysmography) or electrocardiography.
- Maintaining continuous visual and verbal contact with the patient.
- In the event that patient rescue is required, an external defibrillator must be immediately available.
- If the patient’s hemodynamic function is compromised during the MRI scan, discontinue the scan, remove the patient from the magnet room, and take the proper measures to restore the patient’s hemodynamic function.
5Post-scan checks
- Program the MRI SureScan mode to Off as soon as the scan is complete.
- Do not leave the device in MRI SureScan mode after the scan is complete. Tachyarrhythmia detection and therapy are suspended while the MRI SureScan mode is programmed to On.
- The system automatically programs the MRI SureScan mode to Off 6 hours after it is programmed to On.
6Other information
- It is not recommended to perform MRI scans during the lead maturation period (approximately 6 weeks) because MRI scans during this period have not been prospectively studied by Medtronic.
- Scanning patients who have multiple MR Conditional devices present is acceptable as long as the MR labeling conditions for all implants can be satisfied.
- Do not bring the Medtronic programmer, Patient Assistant, or patient monitor into the examination room (MRI magnet room). They are MR Unsafe.
- Use caution if using wireless telemetry while the patient is in the MRI magnet room. Wireless telemetry may cause image distortion.
- MRI scan artifacts and distortion resulting from the presence of the device and the leads within the field of view must be considered when selecting the field of view and MRI scanning parameters. These factors must also be considered when interpreting the MRI scans. Significant MRI scan distortion will result from the presence of the device within the field of view.
- The patient may feel sensations of warmth or vibration in the implant site during the MRI scan. Tolerable levels of these sensations do not indicate that patient safety has been compromised.
These conditions are based on the source document shown below (revision and date). Before scanning, verify the patient's complete system (device, leads, and any other implants) against the latest manufacturer labeling.