User's Manual

18. SUPPLEMENTAL INFORMATION
Clinical data presented in this section are from the SafeR (AAI <> DDD) clinical study. SafeR
(AAI <> DDD) operation in PLATINIUM is similar to that in the Symphony pacemaker. The
data provided are applicable to PLATINIUM 4LV SonR CRT-D 1844.
ADVERSE EVENTS IN THE SAFER (AAI <> DDD) STUDY
Clinical study of the SafeR (AAI <> DDD) included 45 Symphony 2550 devices implanted in
45 patients. No serious adverse events were device- or feature-related. There were no deaths
in the study.
Table 1: Summary of Symphony safety data during study
Patients Number of events
Number
of pa-
tients
% 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 (AAI <> DDD)
0 0 0 0
Non-serious pacemaker related events out-
side 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.
SAFER (AAI <> DDD) CLINICAL STUDY
SafeR (AAI <> DDD) mode in PLATINIUM is similar to that in Symphony.
The differences in SafeR (AAI <> DDD) mode between the two devices are:
― To prevent long RR intervals during VT/VF, SafeR (AAI <> DDD) has no effect during
VT/VF therapy, electrophysiologic studies, and post-shock recovery.
― The maximum acceptable AV delay for first degree AV block varies as a function of
pacing rate.
― PLATINIUM requires a ventricular sensed event to atrial paced event (RA) interval of at
least 100 ms. Therefore, the device lengthens the atrial escape interval so that it ends at
least 102 ms after the ventricular event.
18.1.
18.2.
18. SUPPLEMENTAL INFORMATION
SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 49