User's Manual

US-ENGLISH – 27
Table 1: Summary of Symphony safety data during study
Patients
Number of events
Number
of
patients
% of
patients
Number
of events
Events
per device
year (a)
Deaths
0
0
0
0
Explants
0
0
0
0
Serious pacemaker
related events outside
the use of SafeR
0
0
0
0
Non-serious
pacemaker related
events outside the
use of SafeR
0
0
0
0
Serious events due to
the use of SafeR
0
0
0
0
Non-serious events
related due to the
use SafeR
13
28.9
15
3.2
Serious non-
pacemaker related
events
6
13.3
9
1.9
Non-serious non-
pacemaker related
events
8
17.8
8
1.7
(a) 4.74 device years
Non-serious events due to the use of SafeR 2 included: delay in
switching on 2nd degree AV block, inappropriate classification of a
PAC, disagreement between markers and recorded EGM, atrial
pacing above the maximum rate, recycling on an r-wave in a
refractory period, and disagreement in the statistics for switches to
DDD. No patient symptoms were associated with these events.