2-14
MRI Scan Procedure Protocol
During the Scan
NOTE: If the time remaining is not sufficient for the patient to undergo the MRI scan, re-
interrogation of the device will reset the Time-out value to the start of the originally programmed
timer setting.
WARNING: When the Time-out parameter is programmed to a value other than Off, the patient
must be out of the scanner before the time programmed elapses. Otherwise, the patient will no
longer meet Conditions of Use ("MRI Conditions of Use" on page 1-4).
Image distortion must be considered when planning an MRI scan, and when interpreting MRI
images of fields containing the pulse generator and/or leads. Pulse generator artifacts extend
beyond the margin of the device in all directions. Only minor artifacts are present around the
pacing lead. Some artifacts include moderate spatial distortion beyond the boundaries of the
visible pulse generator artifact. Gradient Recalled Echo artifacts are generally larger and more
prone to have accompanying spatial distortion than Spin Echo artifacts.
DURING THE SCAN
Patient Monitoring
Normal voice and visual contact, as well as pulse oximetry and/or ECG, must be monitored for
the duration of the scan.
WARNING: Ensure that an external defibrillator and medical personnel skilled in cardio-
pulmonary resuscitation (CPR) are present during the MRI scan should the patient require
external rescue.
WARNING: If the MRI Protection Time-out value of Off is combined with a Pacing Mode of Off,
the patient will not receive pacing until the pulse generator is programmed out of MRI Protection
Mode and back to normal operation. It is recommended to have the Programmer/Recorder/
Monitor (PRM) near the MRI room in case the patient develops the urgent need for pacing.
Patients with the following conditions may have increased risk of developing transient pacing-
dependence:
• A history of syncope related to bradyarrhythmia
• A history of syncope of unknown etiology
• Sinus pauses (Pause > 2 s), AV block permanently or intermittently
• At risk for intermittent AV block (for example, those with progressive AV block, or a history of
unexplained syncope)
• At risk for trifascicular block (alternating bundle branch block or PR interval > 200 ms with
LBBB or other bifascicular block)
WARNING: The Programmer/Recorder/Monitor (PRM) is MR Unsafe and must remain outside
the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance
Document for Safe MR Practices
2
. Under no circumstances should the PRM be brought into the
MRI scanner room, the control room, or the MRI site Zone III or IV areas.
AFTER THE SCAN
WARNING: Exit MRI Protection Mode after MRI scanning is completed. If the MRI Protection
Time-out value of Off is selected, the pulse generator will remain permanently in the MRI
Protection Mode until it is programmed otherwise. Prolonged use of the MRI Protection Mode
(such as may occur when the Time-out feature is programmed to Off) may increase the rate of
2. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.
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