User Manual Part 4

D-28
CLINICAL STU DY - CONTAK CD
Table D-24. Caus e of death for operative m ortal ity
Cause o f Death
Implants
N=501
Attempts
N=66
Total
a
N=567
Cardiac: pump failure
5
16
Cardiac: arrhythmic
213
Noncardiac 2 0 2
Unknown 1 0 1
Tota l 10 2 12
a. All patients attempted or implanted, N = 567.
System Safety Profile––analysis of system safety was performed on the
complication-free rate of device-related adverse events, regardless of whether
or not they were related to the investigational device (Figure D-11 on page
D-29). Table D-25 on page D-28 outlines the device related complications. This
study used an acceptance criterion such that the lower boundary of the 95%
confidence interval could not be less than 70%.
Table D-25. Device-related complicatio ns
Complication
a
#ofpts %ofpts
All patients implanted (N = 448)
Loss of LV capture
31 6.9
Loss of right atrial capture
7
1.6
Ventricular oversensing 6 1.3
Extracardiac stimulation
5
1.1
All patients attempted or implanted (N = 51 7)
Infections
7
1.4
a. This table represents patients attempted or implanted with the EASYTRAK lead; most common (> 1%) device-related
complications reported.
- DRAFT -