User Manual Part 3

B-6
CLINICAL STUDY - COMPANION
Table B-1. Device- and procedure-related adverse events (continued)
Total Events
(Patients)
% Comps
(Patients)
%Obs
(Patients)
Pericardial effusion 1 (1) 0.2 (1) 0.0 (0)
Pericarditis
2 (1) 0.0 (0) 0.2 (1)
Placement difficulty, stylet related 1 (1) 0.2 (1) 0.0 (0)
Pleural effusion 1 (1) 0.2 (1) 0.0 (0)
Pleurisy
2 (1) 0.0 (0) 0.2 (1)
Pocket erosio n/extrusion 1 (1) 0.2 (1) 0.0 (0)
Anxiety
1 (1) 0.0 (0) 0.2 (1)
Respiratory a rrest
1 (1) 0.2 (1) 0.0 (0)
Ventricular fibrillation 1 (1) 0.0 (0) 0.2 (1)
a. Observations and complications may not sum to total because some patient may have events in both c ategories.
b. Physiological reaction includes: swelling, rash, and/or drainage.
Table B-2. Patient-related adverse events
Total Events (Patients) % of Patients with
Events
Events/Patient Yea r
CRT-D OPT CRT-D
N=595
Patients
OPT
N=308
Patients
CRT-D
281 Years
OPT
134 Years
Total Patient Related
Adverse Events
1437 (443) 625 (207)
74.5 67.2
5.11 (1437) 4.66 (625)
Cardiovascular Related
Events
814 (351) 399 (176)
59.0 57.1
2.90 (814) 2.98 (399)
Congestive heart failure
a
269 (166) 185 (111)
27.9 36.0
0.96 (269) 1.38 (185)
Chest pain 83 (65) 50 (37)
10.9 12.0
0.30 (83) 0.37 (50)
Supraventricular
tachyarrhythmia
69 (56) 11 (11)
9.4 3.6
0.25 (69) 0 .08 (11)
Ventricular tachyarrhythmia
66 (51) 16 (15)
8.6 4.9
0.23 (66) 0.12 (16)
Electrolyte/lab 51 (42) 17 (16)
7.1 5.2
0.18 (51) 0.13 (17)
Hypotension
42 (40) 16 (15)
6.7 4.9
0.15 (42) 0.12 (16)
Dizziness, cause
undetermined
33 (30) 26 (23)
5.0
7.5
0.12 (33) 0.19 (26)
Renal failure 40 (29) 16 (14)
4.9 4.5
0.14 (40) 0.12 (16)
Fatigue
27 (25) 12 (12)
4.2 3.9
0.10 (27) 0.09 (12)
Bradyarrhythmia
32 (30) 5 (5)
5.0 1.6
0.11 (32) 0.04 (5)
- DRAFT -