Use Instructions

28
Implanted Subjects
(N=125)
Event
Number
of Events
Number
of
Subjects
Event
Rate
Hypertensive Crisis
0
0
0.0%
Severe Complication of HF Treatment
0
0
0.0%
Systemic and Pulmonary Thromboembolism
0
0
0.0%
Infection Requiring Explant
2
2
1.6%
Cranial Nerve Damage
0
0
0.0%
Non-Elective Major Restorative Procedures
0
0
0.0%
Total
4
4
3.2%
Out of the 125 subjects implanted in the Intended Use Population, 9 subjects experienced
12 system- or procedure-related complications within six months of implant. The
complication-free rate in the Intended Use Population is 92.8%. A listing of the system or
procedure related complications is shown in Table 7 below.