Trial Outcomes & Findings for RNS® System Feasibility Study (NCT NCT00079781)
NCT ID: NCT00079781
Last Updated: 2014-01-29
Results Overview
RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not. This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. The primary safety outcome measure was met.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Initial implant through 1 month post-implant
Results posted on
2014-01-29
Participant Flow
Subjects were recruited at Level 4 epilepsy centers, as categorized by the National Association of Epilepsy Centers (NAEC), through the United States.
In order to undergo initial implant, subjects were required to have successfully completed the non-significant risk Prospective Seizure Frequency (PSF) study, which gathered baseline characteristics and data including (pre-implant) seizure frequency. Subjects were required to maintain a minimum seizure frequency and remain on the same AED regimen.
Participant milestones
| Measure |
Open Label Group
Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
|
Treatment Group
Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
|
Sham Group
Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
|
|---|---|---|---|
|
Pre-implant Period
STARTED
|
45
|
10
|
15
|
|
Pre-implant Period
COMPLETED
|
42
|
9
|
14
|
|
Pre-implant Period
NOT COMPLETED
|
3
|
1
|
1
|
|
Evaluation Period
STARTED
|
42
|
9
|
14
|
|
Evaluation Period
COMPLETED
|
42
|
9
|
14
|
|
Evaluation Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Follow-up Period
STARTED
|
42
|
9
|
14
|
|
Follow-up Period
COMPLETED
|
38
|
9
|
12
|
|
Follow-up Period
NOT COMPLETED
|
4
|
0
|
2
|
Reasons for withdrawal
| Measure |
Open Label Group
Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
|
Treatment Group
Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
|
Sham Group
Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
|
|---|---|---|---|
|
Pre-implant Period
Withdrawal by Subject
|
2
|
0
|
0
|
|
Pre-implant Period
Did not meet I/E criteria
|
1
|
1
|
1
|
|
Follow-up Period
Withdrawal by Subject
|
3
|
0
|
1
|
|
Follow-up Period
Lost to Follow-up
|
1
|
0
|
0
|
|
Follow-up Period
Death
|
0
|
0
|
1
|
Baseline Characteristics
RNS® System Feasibility Study
Baseline characteristics by cohort
| Measure |
Open Label Group
n=42 Participants
Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
|
Treatment Group
n=9 Participants
Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
|
Sham Group
n=14 Participants
Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
65 participants
n=4 Participants
|
|
Duration of epilepsy
|
17.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
17.4 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
17.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
17.5 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Number of antiepileptic drugs (AEDs) used over lifetime
|
8.0 AEDs
STANDARD_DEVIATION 2.6 • n=5 Participants
|
7.3 AEDs
STANDARD_DEVIATION 2.4 • n=7 Participants
|
6.6 AEDs
STANDARD_DEVIATION 2.7 • n=5 Participants
|
7.6 AEDs
STANDARD_DEVIATION 2.6 • n=4 Participants
|
|
Seizure onset location
Mesial temporal lobe ONLY
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Seizure onset location
Other
|
34 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Number of seizure foci
Bifocal
|
15 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Number of seizure foci
Unifocal
|
27 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Prior intracranial monitoring for seizure localization
Prior intracranial monitoring
|
32 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
53 participants
n=4 Participants
|
|
Prior intracranial monitoring for seizure localization
NO prior intracranial monitoring
|
10 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Prior therapeutic surgery for epilepsy
Prior therapeutic surgery for epilepsy
|
18 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Prior therapeutic surgery for epilepsy
NO prior therapeutic surgery for epilepsy
|
24 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Prior vagal nerve stimulator (VNS)
Yes
|
16 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Prior vagal nerve stimulator (VNS)
No
|
26 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Anatomical brain abnormality (by neuroimaging)
Yes
|
18 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Anatomical brain abnormality (by neuroimaging)
No
|
24 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
34 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Initial implant through 1 month post-implantRNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not. This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. The primary safety outcome measure was met.
Outcome measures
| Measure |
All Participants
n=65 Participants
Open Label Group, Treatment Group, and Sham Group combined.
|
|---|---|
|
Acute SAE Rate
|
6.2 percentage of participants
Interval 2.4 to 14.8
|
PRIMARY outcome
Timeframe: Initial implant through 3 months post-implantThe RNS® System Short-term Chronic SAE rate = the percentage of implanted subjects having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not. This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 46%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. The primary safety outcome measure was met.
Outcome measures
| Measure |
All Participants
n=65 Participants
Open Label Group, Treatment Group, and Sham Group combined.
|
|---|---|
|
Short-term Chronic SAE Rate
|
9.2 percentage of participants
Interval 4.3 to 18.7
|
PRIMARY outcome
Timeframe: Pre-implant baseline through 4 months post-implantPercentage of subjects with a 50% or greater reduction in mean seizure frequency during the post-implant Evaluation Period (4 months or 112 days) compared to pre-implant baseline (collected during the Prospective Seizure Frequency study). The primary effectiveness endpoint would be met with an observed responder rate of 13% or more. The effectiveness endpoint was only calculated for the Treatment Population. The endpoint was used to support a Pivotal Study, not to demonstrate efficacy when compared to a control/sham group. The primary effectiveness endpoint was met.
Outcome measures
| Measure |
All Participants
n=51 Participants
Open Label Group, Treatment Group, and Sham Group combined.
|
|---|---|
|
Responder Rate
|
24 Percent of participants
|
Adverse Events
Treatment Population
Serious events: 22 serious events
Other events: 48 other events
Deaths: 0 deaths
Sham Group
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Population
n=51 participants at risk
Open Label Group and Treatment Group combined.
|
Sham Group
n=14 participants at risk
Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period). Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Investigations
Biopsy lung
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Coma
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Complex partial seizures increased
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Confusional state
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Contusion (due to seizure)
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Cystitis
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Death
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Psychiatric disorders
Depression
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Device lead damage
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Investigations
EEG monitoring
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Implant site erosion
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Joint injury (due to seizure)
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Pregnancy, puerperium and perinatal conditions
Live birth
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Surgical and medical procedures
Medical device removal
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Nonconvulsive status epilepticus
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Postictal paralysis
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Premature battery depletion
|
11.8%
6/51 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Investigations
Psychiatric evaluation
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Simple partial seizures increased (motor)
|
2.0%
1/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Skin laceration (due to seizure)
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Psychiatric disorders
Suicide attempt
|
2.0%
1/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Tonic-clonic seizures
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Tonic-clonic seizures exacerbated
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Tonic-clonic seizures increased
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
Other adverse events
| Measure |
Treatment Population
n=51 participants at risk
Open Label Group and Treatment Group combined.
|
Sham Group
n=14 participants at risk
Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period). Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Adverse drug reaction
|
11.8%
6/51 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Psychiatric disorders
Affect lability
|
3.9%
2/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Psychiatric disorders
Agitation
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Psychiatric disorders
Anxiety
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Aphasia
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Ataxia
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Back injury (due to seizure)
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.7%
8/51 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Balance disorder
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Bradyphrenia
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Complex partial seizures
|
5.9%
3/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Complex partial seizures exacerbated
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Complex partial seizures increased
|
25.5%
13/51 • Number of events 19 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
42.9%
6/14 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Concussion (due to seizure)
|
3.9%
2/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Confusional state
|
5.9%
3/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
3/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Contusion (due to seizure)
|
5.9%
3/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Psychiatric disorders
Depression
|
15.7%
8/51 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Psychiatric disorders
Depression suicidal
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Device interaction
|
11.8%
6/51 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
4/51 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Eye disorders
Diplopia
|
9.8%
5/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Dizziness
|
13.7%
7/51 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Immune system disorders
Drug hypersensitivity
|
5.9%
3/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Dysaesthesia
|
13.7%
7/51 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Dysarthria
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Renal and urinary disorders
Dysuria
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Ear infection
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Surgical and medical procedures
Endodontic procedure
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Eye disorders
Eye pain
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Eyelid ptosis
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Fall
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Fatigue
|
7.8%
4/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
21.4%
3/14 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Gait disturbance
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Hand fracture (due to seizure)
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Head injury (due to seizure)
|
7.8%
4/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Headache
|
27.5%
14/51 • Number of events 22 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
35.7%
5/14 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Vascular disorders
Hypertension
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Hypoaesthesia
|
9.8%
5/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Implant site discharge
|
5.9%
3/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Implant site pain
|
19.6%
10/51 • Number of events 11 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
35.7%
5/14 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Implant site paraesthesia
|
7.8%
4/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Implant site swelling
|
11.8%
6/51 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Influenza
|
9.8%
5/51 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
21.4%
3/14 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Insomnia
|
9.8%
5/51 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
28.6%
4/14 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Joint injury (due to seizure)
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Psychiatric disorders
Libido decreased
|
9.8%
5/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Memory impairment
|
9.8%
5/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
21.4%
3/14 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Migraine
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Multiple injuries (due to seizure)
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
9.8%
5/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Nasopharyngitis
|
29.4%
15/51 • Number of events 21 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
21.4%
3/14 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Gastrointestinal disorders
Nausea
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Night sweats
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Nystagmus
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Oedema peripheral
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Paraesthesia
|
5.9%
3/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.8%
4/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Photophobia
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Photopsia
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Pneumonia
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Post-traumatic headache
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Postictal headache
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Procedural headache
|
47.1%
24/51 • Number of events 24 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
57.1%
8/14 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
7.8%
4/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
7.8%
4/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.9%
2/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
General disorders
Pyrexia
|
3.9%
2/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.7%
7/51 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Respiratory tract infection
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Immune system disorders
Seasonal allergy
|
11.8%
6/51 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Simple partial seizures (motor)
|
9.8%
5/51 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Simple partial seizures (sensory)
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Simple partial seizures increased (motor)
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Simple partial seizures increased (sensory)
|
3.9%
2/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Sinusitis
|
3.9%
2/51 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.9%
3/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Skin laceration (due to seizure)
|
3.9%
2/51 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Somnolence
|
7.8%
4/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
7.8%
4/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
23.5%
12/51 • Number of events 17 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
50.0%
7/14 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Tonic-clonic seizures
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Tonic-clonic seizures exacerbated
|
5.9%
3/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Tonic-clonic seizures increased
|
5.9%
3/51 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
28.6%
4/14 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Tooth infection
|
3.9%
2/51 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Nervous system disorders
Tremor
|
15.7%
8/51 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
0.00%
0/14 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Upper respiratory tract infection
|
13.7%
7/51 • Number of events 10 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Eye disorders
Vision blurred
|
7.8%
4/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Eye disorders
Visual disturbance
|
0.00%
0/51 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
14.3%
2/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
|
Investigations
Weight increased
|
2.0%
1/51 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
7.1%
1/14 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a positive or negative change in subject's physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in: * significant risks/consequences to patient's acute or long-term health * serious injury or death * hospitalization or invasive medical intervention required to alleviate event
|
Additional Information
Dr. Martha Morrell, Chief Medical Officer
NeuroPace, Inc.
Phone: 650-237-2776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Each Investigator, Coordinator, and Institution agree to submit publications to the RNS® System Study Publication Committee for review prior to submission for publication (at least 30 days for manuscripts and at least 7 days for abstracts) to assure that publication does not compromise the scientific integrity of the study or contain confidential NeuroPace information. NeuroPace may require that presentation/publication be withheld for up to 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER