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Boston Scientific L310 - Page 21

Boston Scientific L310
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Introduction to MR Conditional Pacing
Potential Adverse Events
1-15
• Patient discomfort due to slight movement or heating of the device
• Side effects of MRI Protection Mode pacing at elevated fixed rate and increased output
including reduced exercise capacity, acceleration of heart failure, and competitive pacing/
arrhythmia induction
• Syncope
MRI scanning of patients when the Conditions of Use are NOT met could result in the following
potential adverse events:
• Arrhythmia induction
• Bradycardia
• Damage to the pulse generator and/or leads
• Erratic pulse generator behavior
• Inappropriate pacing, inhibition of pacing, failure to pace
• Increased rate of lead dislodgement (within six weeks of implant or revision of system)
• Irregular or intermittent capture or pacing
• Pacing threshold changes
• Patient death
• Patient discomfort due to movement or heating of the device
• Physical movement of pulse generator and/or leads
• Sensing changes
• Syncope