Boston Scientific L310 - MRI Site Zone III Exclusions; Precautions; Potential Adverse Events

1-14
Introduction to MR Conditional Pacing
MRI Site Zone III Exclusions
• if the Pacing Mode under MRI Protection Mode settings is programmed to Off; the pulse
generator will continue permanently with the Pacing Mode programmed to Off, and the
patient will not receive pacing therapy until the pulse generator is replaced
MRI Site Zone III Exclusions
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
5
. 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.
WARNING: Implant of the system cannot be performed in an MRI site Zone III (and higher) as
defined by the American College of Radiology Guidance Document for Safe MR Practices
6
.
Some of the accessories packaged with pulse generators and leads, including the torque wrench
and stylet wires, are not MR Conditional and should not be brought into the MRI scanner room,
the control room, or the MRI site Zone III or IV areas.
Precautions
CAUTION: The physician choosing MRI Protection Mode parameter values will need to
exercise professional judgment to determine an individual patient’s ability to tolerate the pacing
parameters required for MR Conditional scanning, in conjunction with the physical conditions
required during a scan (for example, prolonged time in a supine position).
CAUTION: If the MR Conditional Pacing System enters Safety Core Operation during MRI
Protection Mode and the pacing mode was set to a value other than Off, MRI Protection Mode
pacing will be automatically switched to VOO mode, RV bipolar configuration (sensing and
pacing), 5.0 V pace pulse amplitude, 1.0 ms pulse width, and 72.5 min
-1
pacing rate as the safety
mode.
CAUTION: The presence of the implanted Pacing System may cause MRI image artifacts (see
"3. Preparing the Patient for the Scan" on page 2-13).
NOTE: All normal risks associated with an MRI procedure apply to MRI scans with the MR
Conditional Pacing System. Consult MRI scanner documentation for a complete list of risks
associated with MRI scanning.
NOTE: Other implanted devices or patient conditions may cause a patient to be ineligible for an
MRI scan, independent of the status of the patient’s ImageReady MR Conditional Pacing
System.
POTENTIAL ADVERSE EVENTS
Potential adverse events differ depending on whether the MRI Conditions of Use ("MRI
Conditions of Use" on page 1-4) are met. For a complete list of potential adverse events, refer to
the Physician's Technical Manual for the pulse generator.
MRI scanning of patients when the Conditions of Use are met could result in the following
potential adverse events:
• Arrhythmia induction
• Bradycardia
• Patient death
5. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.
6. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.