User's Manual

5. ADVERSE EVENTS
Clinical data presented in this section are from the MSP clinical study.
PLATINIUM 4LV SonR CRT-D 1844 is similar in design and function to the ALTO 2 MSP and
OVATIO CRT-D devices. The data provided are applicable to PLATINIUM 4LV SonR CRT-D
1844.
MSP STUDY
Sorin conducted an international, multi-center, randomized clinical trial of its cardiac
resynchronization therapy system. Investigators attempted to implant study devices in 190
patients. A total of 182 patients received study devices and had an exposure of over 165
device years. Of those patients, 19 received OVATIO CRT-D, 160 received ALTO 2 MSP, and
3 received ALTO MSP. The clinical data collected on ALTO MSP, ALTO 2 MSP and OVATIO
CRT-D are applicable to PLATINIUM 4LV SonR CRT-D 1844. The table below summarizes
the adverse events observed for the CRT-D system. No deaths were related to the system.
Event # of Pa-
tients
% of Pa-
tients
# 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 decompensa-
tion
3 1.6 3 0.2
Multi-organ dysfunction 2 1.1 2 0.1
Complications related to the sys-
tem
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 im-
plant 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
Serious adverse events not related
to the system
85 44.7 176 10.8
Worsening CHF/CHF decompensation 24 12.6 42 2.1
Atrial fibrillation/flutter 14 7.4 14 0.7
Not Serious events not related to
the system
58 30.5 121 7.4
5.1.
5. ADVERSE EVENTS
16 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A