User's Manual

16 – US-ENGLISH
Event
# of
Patients
% of
Patients
# of
Events
Events/
100
Device-
Years
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,