User's Manual

US-ENGLISH – 15
Event
# of
Patients
% of
Patients
# of
Events
Events/
100
Device-
Years
Deaths not related to the
system
16
8.4
16
0.8
Cardiac arrest
5
2.6
5
0.3
Worsening CHF / CHF
decompensation
3
1.6
3
0.2
Multi-organ dysfunction
2
1.1
2
0.1
Complications related to the
system
28
14.7
35
2.1
Dislodgment or migration
9
4.7
11
0.6
Extracardiac stimulation
(e.g., phrenic stim)
9
4.7
9
0.5
Complications related to the
implant procedure
18
9.5
21
1.3
Dislodgment or migration
4
2.1
4
0.2
Observations related to the
system
23
12.1
27
1.7
Extracardiac stimulation
(e.g., phrenic stim)
12
7.9
15
0.8
Observations related to the
implant procedure
24
12.6
28
1.7
Heart block
6
3.2
6
0.3
Extracardiac stimulation
(e.g., phrenic stim)
3
1.5
5
0.3