User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-27
• Trans ient renal failure (5 patients, 1.0%)
These events were typically resolved without intervention and no permanent
long-term sequelae were reported.
Severe, Device-Related Adverse Events and Operative Mortality––the
incidence of severe, device-related events was reported in 7 of 567 patients
(1.2%); this was significant ly less th an the h yp othesized rate of 20% (p <
0.01) (Table D-22 on page D-27). Table D-23 on page D-27 reports system,
device-related, severe adverse events observed during the CONTAK CD Study.
Table D-22. Adve rse events and operative mortality
Measurement
a
N
%95%CI
Severe, Device-Related Adverse Events (Type I)
b
7
1.2
(0.3, 2 .1)
All-Cause Operative Mortality (< = 30 Days Post Implant)
12 2.1
(0.9, 3 .3)
a. All patients attempted or implanted, N = 567
b. Percent is of patients with at least one event.
Tab le D-23. System, device-related, severe adverse events
Adverse Event
a
# of pts % of pts (95% CI)
Tele m etr y d i fficu l t y; device explanted
2
0.4 ( 0.0–0.9)
Ventricular tachycardia during CPX testing
1
0.2 ( 0.0–0.5)
Coronary sinus perforation
1
0.2 ( 0.0–0.5)
Inappropriate shock d ue to oversensing 1
0.2 ( 0.0–0.5)
Lead dislodgment 1
0.2 ( 0.0–0.5)
Anaphylaxis in asso ciation with use of a pulmonary artery
catheter
1
0.2 ( 0.0–0.5)
a. All patients attempted or implanted, N = 567
Operative mortality, definedasdeathfromanycausewithin30daysofimplant,
was reported in 12 of 567 patients (2.1%) undergoing the implant procedure.
The outcome is significantly less than the hypothesized rate of 9% (p < 0.01).
Table D-24 on page D-28 reports the cause of death for operative mortality.
- DRAFT -