User Manual Part 4

D-4
CLINICAL STU DY - CONTAK CD
Tab le D-1. A dverse events through randomization perio d (continued)
# Of Events
(# of pts)
%
Complications
(Patients)
Complicatio ns
per 100
Device Months
(Events)
%
Observations
(Patients)
Observations
per 100
Device Months
(Events)
Cardiovascular-Related Events
AV Block
3 (3) 0.0 (0) 0.0 (0) 0.6 (3) 0.1 ( 3)
Arrhythmia - SVT 49 (42) 0.2 (1) 0.0 (1) 7.9 (41) 1.8 (48)
Arrhythmia - VT
20 (17) 1.0 (5) 0.2 (5) 2.7 (14) 0.6 (15)
Arrhythmia - brady
16 (14) 0.2 (1) 0.0 (1) 2.5 (13) 0.6 (15)
Cardiac arrest 2 (2) 0.4 (2) 0.1 (2) 0.0 (0) 0.0 (0)
Chest pain 30 (20) 1.0 (5) 0.2 (5) 3.1 (16) 1.0 (25)
Coagulopathy 3 (3) 0.2 (1) 0.0 (1) 0.4 (2) 0.1 (2)
Congestive heart
failure
140 (91) 3.5 (18) 0.7 (18) 16.1 (83) 4.7 (122)
Distal
thromboemboli
3 (2) 0.0 (0) 0.0 (0) 0.4 (2) 0.1 ( 3)
Dizziness
17 (17) 0.0 (0) 0.0 (0) 3.3 (17) 0.7 (17)
Dyspnea
(shortness of
breath)
16 (13) 0.0 (0) 0.0 (0) 2.5 (13) 0.6 (16)
Fatigue
10 (10) 0.0 (0) 0.0 (0) 1.9 (10) 0.4 (10)
Hypertension
1 (1) 0.0 (0) 0.0 (0) 0.2 (1) 0.0 ( 1)
Hypotension
11 (9) 0.2 (1) 0.0 (1) 1.7 (9) 0.4 (10)
Myocardial
infarction
2 (2) 0.0 (0) 0.0 (0) 0.4 (2) 0.1 ( 2)
Pacemaker
syndrome
1 (1) 0.0 (0) 0.0 (0) 0.2 (1) 0.0 ( 1)
Palpitations
2 (2) 0.0 (0) 0.0 (0) 0.4 (2) 0.1 ( 2)
Pulmonary edema
6 (6) 0.4 (2) 0.1 (2) 0.8 (4) 0.2 ( 4)
Shock 4 (4) 0.2 (1) 0.0 (1) 0.6 (3) 0.1 (3)
Stroke syndrome or
CVA
4 (4) 0.0 (0) 0.0 (0) 0.8 (4) 0.2 ( 4)
Syncope 9 (9) 0.0 (0) 0.0 (0) 1.7 (9) 0.3 ( 9)
Thrombosis
3 (3) 0.0 (0) 0.0 (0) 0.6 (3) 0.1 ( 3)
Vascular related
6 (6) 1.0 (5) 0.2 (5) 0.2 (1) 0.0 ( 1)
- DRAFT -