User's Manual

US-ENGLISH – 21
 Adverse events
Event US
(N=22)
Number of
events*
Number of
patients
Percent of
patients
Intent to treat
but did not
0
0
0.0
Non-device
related death
0
0
0.0
Explant
0
0
0.0
Complication
0
0
0.0
Observation
0
0
0.0
Serious non-
related other
than death
1
1
4.5
Event Europe
(N=38)
Number of
events*
Number of
patients
Percent of
patients
Intent to treat
but did not
0
0
0.0
Non-device
related death
1
1
2.6
Explant
1
1
2.6
Complication
3
2
5.3
Observation
18
14
36.8
Serious non-
related other
than death
12
7
18.4