MRI Approach
Medtronic has spent 12 years conducting extensive research and rigorous testing to design a breakthrough pacing system—both pacemaker and lead—that when used together allows pacemaker patients to safely undergo MRI scans under certain conditions.
Powerful fields produced during MRI have the potential to induce hazardous effects on patients and their implantable cardiac devices. Medtronic has implemented system design changes specifically engineered for the MR environment.
| Potential Hazard |
Risks for Patient and Device |
System Design Changes |
| Force, Torque, Vibration |
- Surrounding tissue damage
- Lead dislodgement
- System damage
- Patient discomfort
|
- Made internal circuitry changes to prevent MRI forces from disrupting the device's operation
- Significantly reduced ferromagnetic components to decrease the susceptibility to magnetic attraction
|
| Induced Voltage by Gradient and RF Fields |
- Cardiac arrhythmias
- Accelerated pacing beyond rate limit
- Inhibition of pacing support
- Damage to mechanical integrity
|
- Made internal circuitry changes to prevent MRI forces from disrupting the device’s operation
- Significantly reduced ferromagnetic components to decrease the susceptibility to magnetic attraction and the resulting corruption of normal functionality
- Modified the device design to accommodate gradient field energy induced into the device
- Modified the device design to minimise the gradient field energy coupled to the lead tip, thereby reducing the potential for gradient induced cardiac stimulation
- Created SureScan™ mode to ensure appropriate device operation and pacing therapy
|
| Lead Tip Heating |
- Tissue damage
- Loss of sensing and/or pacing capture
- Subsequent threshold changes
- Patient discomfort
|
- To prevent interactions with gradient and RF fields, including lead tip heating
|
| Device Malfunction |
- Loss of therapy
- Pacing mode change
- Device reset
- Erroneous diagnostic data
|
- Made internal circuitry changes to prevent MRI forces from disrupting the device’s operation
- Significantly reduced ferromagnetic components to decrease the susceptibility to magnetic attraction and the resulting corruption of normal functionality
- Modified the device design to accommodate gradient field energy induced into the device
- Created SureScan™ mode to ensure appropriate device operation and pacing therapy
|
*MR Conditional when used according to labeling
The SureScan™ Pacing Systems are labeled as MR Conditional and have received CE Mark approval for use with MRI:
Physicians and their patients should accept nothing less than this absolute commitment to safety and quality.
CapSure Sense MRI™Lead Overview Brochure 
