User's Manual

US-ENGLISH – 17
Extracardiac stimulation
(e.g., phrenic stim)
3
1.5
5
0.3
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