User's Manual

5. ADVERSE EVENTS
Clinical data presented in this section are from the MSP clinical study. PLATINIUM 4LV CRT-
D 1744is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The
data provided are applicable to PLATINIUM 4LV CRT-D 1744.
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 CRT-D 1744. 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
Pain (in back, arms, chest, shoulder,
groin, head, other)
10 5.3 13 0.7
5.1.
5. ADVERSE EVENTS
16 SORIN – PLATINIUM 4LV CRT-D 1744 – U904A