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Table 1: Risks Associated with Implantation
Common (greater than or equal to 5%)
•
Post-procedural pain, bruising, and discomfort at insertion site
•
Bleeding
•
Infection at site of insertion
•
Pocket hematoma
•
Migration of leads
•
Migration of implanted IPG
Uncommon (between 1-5%)
•
Chest trauma (such as a collapsed lung or bleeding into the
chest)
•
Generator complication
•
Cardiac perforation (puncture of the heart caused by the
leads)
•
Endocarditis (infection of the heart valves)
•
Arrhythmia (irregular heartbeat, including heartbeats that are
too slow or too fast)
•
Tricuspid valve damage (the valve between the right upper
and lower chambers of the heart that prevents blood from
flowing back into the upper chamber), possibly leading to
tricuspid valve regurgitation or leakage
•
Vessel trauma (perforation, dissection, or rupture)
•
Thrombosis (formation of blood clots in the veins)
•
Damage to the specific type of heart tissue responsible for
triggering heartbeats (i.e., the cardiac conduction system)
•
Allergic reaction
Rare (less than 1%)
•
Bradycardia (slow heart rate)
•
Cardiac tamponade (build up of fluid around the heart that can
be life-threatening)
•
Myocardial infarction (heart attack)
•
Mini stroke (TIA), or stroke
•
Death