User Manual Part 4

D-2
CLINICAL STU DY - CONTAK CD
EASYTRAK lead. An additional 510 patients initia lly underwent an implant
procedure to receive the Model 1823 CONTAK CD CRT-D along with the
EASYTRAK (Models 4510/4511/4512/4513) coronary venous, single-electrode
pace/sense lead for a total of 517 patients who underwent an EASYTRAK
lead implant procedure. In 69 patients the EASYTRAK lead implant attempt
was unsuccessf ul.
Table D-1 on page D-2 provides information on all adverse events reported
from implant through the randomization period in patients attempted or
implanted with the EASYTRAK lead. During this period, a total of 765 events
were reported in 310 patients. Of th ese, 15 5 were classified as complications,
and 610 were classified as observation s.
Table D-1. Adverse events throug h randomization period
# Of Events
(# of pts)
%
Complications
(Patients)
Complicatio ns
per 100
Device Months
(Events)
%
Observations
(Patients)
Observations
per 100
Device Months
(Events)
Total Adverse
Events
765 (310) 23.4 (121) 6.0 (155) 51.8 (2 68) 23.5 (610)
PG-Related Events
Migration of device 1 (1) 0.0 (0) 0.0 (0) 0.2 (1) 0.0 (1)
Pacemaker-mediated
tachycardia ( PMT)
3 (3) 0.0 (0) 0.0 (0) 0.6 (3) 0.1 ( 3)
Telemetry difficulty 1 (1) 0.2 (1) 0.0 (1) 0.0 (0) 0.0 ( 0)
LV Lead-Related Events
Loss of capture 43 (41) 5.6 (29) 1.1 (29) 2.5 (13) 0.5 (14)
Inappropriate shock
due to oversensing
1 (1) 0.0 (0) 0.0 (0) 0.2 (1) 0.0 ( 1)
Insulation breach
observed
1 (1) 0.2 (1) 0.0 (1) 0.0 (0) 0.0 ( 0)
Multiple count ing
31 (22) 1.0 (5) 0.2 (5) 3.9 (20) 1.0 (26)
Phrenic
nerve/diaphragm
stimulation
15 (15) 0.4 (2) 0.1 (2) 2.5 (13) 0.5 (13)
RA Lead-Related Events
Loss of capture 6 (6) 1.0 (5) 0.2 (5) 0.2 (1) 0.0 (1)
Oversensing 3 (3) 0.0 (0) 0.0 (0) 0.6 (3) 0.1 (3)
Undersensing
1 (1) 0.2 (1) 0.0 (1) 0.0 (0) 0.0 ( 0)
RV Lead-Related Events
- DRAFT -