5. ADVERSE EVENTS
Non-serious pacemaker
related events outside the use
of SafeR (AAI <> DDD)
0
0
0
0
Serious events due to the use
of SafeR (AAI <> DDD)
0
0
0
0
Non-serious events related due
to the use SafeR (AAI <> DDD)
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 (AAI <> DDD) 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.
SORIN – INTENSIA DR 154 – U152A
15
Summary of Contents for Intensia DR 154
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