User Manual

5. ADVERSE EVENTS
Serious adverse events not
related to the system
85 44.7 176 10.8
Worsening CHF/CHF
decompensation
24 12.6 42 2.1
Atrial fibrillation/flutter 14 7.4 14 0.7
Not Serious events not
related to the system
58 30.5 121 7.4
Pain (in back, arms, chest,
shoulder, groin, head, other)
10 5.3 13 0.7
Worsening CHF/CHF
decompensation
13 6.8 16 0.8
Atrial fibrillation/flutter 7 3.7 8 0.4
Ventricular tachycardia 7 3.7 7 0.4
5.2. POTENTIAL ADVERSE EVENTS
Adverse events (in alphabetical order), including those reported in the previous tables,
associated with ICD systems include:
─ Acceleration of arrhythmias (caused by device),
─ Air embolism,
─ Bleeding,
─ Chronic nerve damage,
─ Erosion,
─ Excessive fibrotic tissue growth,
─ Extrusion,
─ Fluid accumulation,
─ Formation of hematomas or cysts,
─ Inappropriate shocks,
─ Infection,
─ Keloid formation,
─ Lead abrasion and fracture,
─ Lead migration/dislodgment,
─ Myocardial damage,
─ Pneumothorax,
─ Shunting current or insulating myocardium during defibrillation with internal or external
paddles,
─ Potential mortality due to inability to defibrillate or pace,
─ Thromboemboli,
─ Venous occlusion,
─ Venous or cardiac perforation.
Patients susceptible to frequent shocks despite antiarrhythmic medical management may
develop psychological intolerance to an ICD system that may include the following:
─ Dependency,
─ Depression,
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SORIN – INTENSIA SonR CRT-D 184 – U150A