User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-3
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)
Loss of capture 10 (9) 0.6 (3) 0.1 (3) 1.2 (6) 0.3 ( 7)
Elevated DFTs
6 (6) 0.4 (2) 0.1 (2) 0.8 (4) 0.2 ( 4)
Inappropriate shock
above rate cutoff
49 (38) 0.4 (2) 0.1 (2) 7.2 (37) 1.8 (47)
Inappropriate shock
due to oversensing
5 (4) 0.0 (0) 0.0 (0) 0.8 (4) 0.2 ( 5)
Nonconversion of
VF
1 (1) 0.2 (1) 0.0 (1) 0.0 (0) 0.0 ( 0)
Oversensing 2 (2) 0.0 (0) 0.0 (0) 0.4 (2) 0.1 (2)
Phantom shock
2 (2) 0.0 (0) 0.0 (0) 0.4 (2) 0.1 ( 2)
Phrenic
nerve/diaphragm
stimulation
5 (5) 0.4 (2) 0.1 (2) 0.6 (3) 0.1 ( 3)
Subtotal
Device-Related
Events
186 (135) 9.5 (49) 2.1 (54) 19.0 ( 98) 5.1 (132)
Procedure-Related Events
AV block
7 (7) 0.0 (0) 0.0 (0) 1.4 (7) 0.3 ( 7)
Coronary sinus
dissection
5 (5) 0.0 (0) 0.0 (0) 1.0 (5) 0.2 ( 5)
Coronary venous
perforation
5 (5) 0.2 (1) 0.0 (1) 0.8 (4) 0.2 ( 4)
Hematoma
11 (10) 0.8 (4) 0.2 (4) 1.2 (6) 0.3 (7)
Hypotension
7 (7) 0.0 (0) 0.0 (0) 1.4 (7) 0.3 ( 7)
Infection,
post-operative
wound
7 (7) 0.6 (3) 0.1 (3) 0.8 (4) 0.2 ( 4)
Pneumothorax
7 (7) 0.8 (4) 0.2 (4) 0.6 (3) 0.1 ( 3)
Post surgical
wound discomfort
10 (9) 0 .2 (1) 0.0 (1) 1.5 (8) 0.3 (9)
Renal failure 5 (5) 0.2 (1) 0.0 (1) 0.8 (4) 0.2 (4)
Other 18 (18) 1.2 (6) 0.2 (6) 2.3 (12) 0.5 (12)
Subtotal
Procedure-Related
Events
79 (71) 3.9 (20) 0.7 (17) 10.0 (51) 2.2 (56)
- DRAFT -