Use Instructions

30
Implanted Subjects
(N=125)
Event
Number of
Events
Number of
Subjects
Event Rate
Heart Failure, Acute Decompensated
Heart Failure
1
1
0.8%
Muscle and Bone
1
1
0.8%
Nerve Damage/Stimulation, Cranial Nerve
Stimulation
1
1
0.8%
Other Nerve, Hoarseness
1
1
0.8%
Respiratory, Other Respiratory, Acute
hypercarbic respiratory failure
1
1
0.8%
Respiratory, Pneumonia
1
1
0.8%
Stroke (CVA), Ischemic
1
1
0.8%
Surgical or Anesthetic Complications,
Infection at Implant Site (No Explant)
1
1
0.8%
Surgical or Anesthetic Complications,
Infection at Implant Site Requiring
Explanation
2
2
1.6%
Surgical or Anesthetic Complications,
Other Surgical Complication, prolonged
intubation
1
1
0.8%
Thromboembolism, Systemic
1
1
0.8%
Total
12
9
7.2%
Implanted Subjects
(N=125)
Event
Number of
Events
Number of
Subjects
Event Rate
Heart Failure, Acute Decompensated Heart
Failure
1
1
0.8%
Muscle and Bone
1
1
0.8%
Nerve Damage/Stimulation, Cranial Nerve
Stimulation
1
1
0.8%
Other Nerve, Hoarseness
1
1
0.8%
Respiratory, Other Respiratory, Acute
hypercarbic respiratory failure
1
1
0.8%
Respiratory, Pneumonia
1
1
0.8%
Severe Complications of Heart Failure
Treatment
1
1
0.8%
Stroke (CVA), Ischemic
1
1
0.8%