Trial Outcomes & Findings for RNS® System Pivotal Study (NCT NCT00264810)
NCT ID: NCT00264810
Last Updated: 2013-08-28
Results Overview
RNS® System Acute SAE Rate = the percentage of implanted subject 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 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 = 15%; upper CI = 20%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Tanriverdi et al., 2009; Wong et al., 2009; Fountas and Smith, 2007; Hamer et al., 2002; Behrens et al., 1997). Primary Safety Outcome Measure was met.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
Initial implant through 1 month post-implant
Results posted on
2013-08-28
Participant Flow
Subjects were recruited at Level 4 epilepsy centers, as categorized by the National Association of Epilepsy Centers (NAEC), through the United States.
Besides continuing to meet all I/E criteria, in order to undergo initial implant and be assigned to a group (randomized), subjects were required to maintain an average of 3 or more disabling partial seizures per month and remain on the same AED regimen (except for acute, intermittent use of benzodiazepines), for 3 consecutive months (12 weeks).
Participant milestones
| Measure |
Treatment Group (Stimulation ON)
Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
|
Sham Group (Stimulation OFF)
Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Baseline
STARTED
|
120
|
120
|
|
Baseline
COMPLETED
|
97
|
94
|
|
Baseline
NOT COMPLETED
|
23
|
26
|
|
Post-Operative Stabilization Period
STARTED
|
97
|
94
|
|
Post-Operative Stabilization Period
COMPLETED
|
97
|
94
|
|
Post-Operative Stabilization Period
NOT COMPLETED
|
0
|
0
|
|
Stimulation Optimization Period
STARTED
|
97
|
94
|
|
Stimulation Optimization Period
COMPLETED
|
96
|
93
|
|
Stimulation Optimization Period
NOT COMPLETED
|
1
|
1
|
|
Blinded Evaluation Period
STARTED
|
96
|
93
|
|
Blinded Evaluation Period
COMPLETED
|
95
|
92
|
|
Blinded Evaluation Period
NOT COMPLETED
|
1
|
1
|
|
Open Label Evaluation Period
STARTED
|
95
|
92
|
|
Open Label Evaluation Period
1-year Post-implant
|
92
|
90
|
|
Open Label Evaluation Period
COMPLETED
|
89
|
86
|
|
Open Label Evaluation Period
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Treatment Group (Stimulation ON)
Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
|
Sham Group (Stimulation OFF)
Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Baseline
Withdrawal by Subject
|
10
|
10
|
|
Baseline
Physician Decision
|
7
|
8
|
|
Baseline
Subject Compliance Failure
|
3
|
3
|
|
Baseline
Insufficient Seizure Frequency
|
2
|
2
|
|
Baseline
Did not Meet/Maintain Study I/E Criteria
|
1
|
2
|
|
Baseline
Other
|
0
|
1
|
|
Stimulation Optimization Period
Withdrawal by Subject
|
1
|
0
|
|
Stimulation Optimization Period
Death
|
0
|
1
|
|
Blinded Evaluation Period
Explant due to infection
|
1
|
1
|
|
Open Label Evaluation Period
Explant due to infection
|
1
|
1
|
|
Open Label Evaluation Period
Death
|
3
|
2
|
|
Open Label Evaluation Period
Pursue Other Treatment Options
|
2
|
3
|
Baseline Characteristics
RNS® System Pivotal Study
Baseline characteristics by cohort
| Measure |
Treatment Group (Stimulation ON)
n=97 Participants
Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
|
Sham Group (Stimulation OFF)
n=94 Participants
Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
34.0 years
n=5 Participants
|
35.9 years
n=7 Participants
|
34.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Duration of epilepsy
|
20.0 years
n=5 Participants
|
21.0 years
n=7 Participants
|
20.5 years
n=5 Participants
|
|
Number of AEDs at enrollment
|
2.8 number of AEDs
n=5 Participants
|
2.9 number of AEDs
n=7 Participants
|
2.8 number of AEDs
n=5 Participants
|
|
Mean seizure frequency
|
33.5 seizures/month
n=5 Participants
|
34.9 seizures/month
n=7 Participants
|
34.2 seizures/month
n=5 Participants
|
|
Seizure onset location
Mesial Temporal lobe ONLY
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Seizure onset location
Other
|
49 participants
n=5 Participants
|
47 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Number of seizure foci
Bifocal
|
48 participants
n=5 Participants
|
58 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Number of seizure foci
Unifocal
|
49 participants
n=5 Participants
|
36 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Prior therapeutic surgery for epilepsy
Yes
|
34 participants
n=5 Participants
|
28 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Prior therapeutic surgery for epilepsy
No
|
63 participants
n=5 Participants
|
66 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Prior EEG monitoring with intracranial electrodes
Yes
|
63 participants
n=5 Participants
|
50 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Prior EEG monitoring with intracranial electrodes
No
|
34 participants
n=5 Participants
|
44 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Prior vagal nerve stimulator (VNS)
Yes
|
30 participants
n=5 Participants
|
34 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Prior vagal nerve stimulator (VNS)
No
|
67 participants
n=5 Participants
|
60 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Anatomical brain abnormality (by neuroimaging)
Yes
|
66 participants
n=5 Participants
|
61 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Anatomical brain abnormality (by neuroimaging)
No
|
31 participants
n=5 Participants
|
33 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Acute benzodiazepine use (does not include daily use)
Yes
|
30 participants
n=5 Participants
|
39 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Acute benzodiazepine use (does not include daily use)
No
|
67 participants
n=5 Participants
|
55 participants
n=7 Participants
|
122 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Initial implant through 1 month post-implantRNS® System Acute SAE Rate = the percentage of implanted subject 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 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 = 15%; upper CI = 20%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Tanriverdi et al., 2009; Wong et al., 2009; Fountas and Smith, 2007; Hamer et al., 2002; Behrens et al., 1997). Primary Safety Outcome Measure was met.
Outcome measures
| Measure |
Implanted Subjects
n=191 Participants
Subjects implanted with the RNS® System
|
Sham Group (Stimulation OFF)
Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Acute SAE Rate
|
12.0 percentage of subjects with ≥ 1 SAE
Interval to 16.5
The lower confidence interval is not required for this endpoint calculation.
|
—
|
PRIMARY outcome
Timeframe: Initial implant through 5 months post-implantRNS® System Short-term Chronic SAE rate = the percentage of implanted subject 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 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 = 42%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Oh et al., 2002; SSED, Activa Tremor Control System P960009; Beric et al., 2001; Behrens et al., 1997; Hariz, 2002; Joint et al., 2002; Koller et al., 2001). Primary Safety Outcome Measure was met.
Outcome measures
| Measure |
Implanted Subjects
n=191 Participants
Subjects implanted with the RNS® System
|
Sham Group (Stimulation OFF)
Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Short-term Chronic SAE Rate
|
18.3 percentage of subjects with ≥ 1 SAE
Interval to 23.4
The lower confidence interval is not required for this endpoint calculation.
|
—
|
PRIMARY outcome
Timeframe: 3 months pre-implant (Baseline Period) compared to months 3, 4 and 5 post-implant (Blinded Evaluation Period)The outcome measure is met when a significantly greater reduction in the frequency of total disabling seizures in seen in the Treatment group when compared to the Sham group, during the Blinded Evaluation Period (BEP) relative to the Pre-Implant Period (Baseline). The outcome measure is the group-by-time interaction term in a generalized estimating equation (GEE), longitudinal regression model, where group refers to therapy allocation (Treatment or Sham), time refers to study period (Baseline or BEP), and the dependent variable is seizure frequency. The outcome measure was a statistically significant group-by-time interaction term, which would demonstrate a significantly greater reduction in seizure frequency in the Treatment group than the Sham group during BEP compared to Baseline Period. Primary Effectiveness Outcome Measure was met. (Note: Disabling seizures = motor simple partial seizures or complex partial seizures with or without secondarily generalized seizures.)
Outcome measures
| Measure |
Implanted Subjects
n=97 Participants
Subjects implanted with the RNS® System
|
Sham Group (Stimulation OFF)
n=94 Participants
Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Change in Frequency of Disabling Seizures
|
-37.9 Seizure frequency % change from Baseline
Interval -46.7 to -27.7
|
-17.3 Seizure frequency % change from Baseline
Interval -29.9 to -2.3
|
Adverse Events
Treatment Group (Stimulation ON)
Serious events: 49 serious events
Other events: 96 other events
Deaths: 0 deaths
Sham Group (Stimulation OFF)
Serious events: 52 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group (Stimulation ON)
n=97 participants at risk
Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
|
Sham Group (Stimulation OFF)
n=94 participants at risk
Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Acquired epileptic aphasia
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Acute psychosis
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Adverse drug reaction
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Investigations
Angiogram cerebral
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Appendicitis
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Apraxia
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Atonic seizures increased
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Investigations
Biopsy brain
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Blindness transient
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Central venous catheterisation
|
1.0%
1/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Complex partial seizures exacerbated
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Complex partial seizures increased
|
7.2%
7/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Contraception
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Conversion disorders
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Convulsive status epilepticus
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Death
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Depression suicidal
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Device lead damage
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Device lead revision
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Immune system disorders
Drug hypersensitivity
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Dysphemia
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Investigations
EEG monitoring
|
8.2%
8/97 • Number of events 11 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Epileptic psychosis
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Generalised oedema
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Hand fracture (due to seizure)
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Head injury (due to seizure)
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Headache
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Hernia
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Hip fracture (due to seizure)
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Hydrocephalus
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Vascular disorders
Hypertension
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Implant site discharge
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Implant site effusion
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Implant site erosion
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Implant site infection
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Implant site infection (due to seizure)
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Implant site pain
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Influenza
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Intracranial hypotension
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Jaw fracture (due to seizure)
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Laceration (due to seizure)
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Pregnancy, puerperium and perinatal conditions
Live birth
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Medical device removal
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Medical device removal (VNS)
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Investigations
Medical observation
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Meningitis bacterial
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Reproductive system and breast disorders
Menstrual disorder
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Nonconvulsive status epilepticus
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Oedema peripheral
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Peritoneal infection
|
1.0%
1/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Pneumonia
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Postictal state
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Premature battery depletion
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Procedural headache
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures (sensory)
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures exacerbated (motor)
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures increased (motor)
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures increased (sensory)
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Skin laceration (due to seizure)
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Subdural haematoma (due to seizure)
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Suicide attempt
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Syncope
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Tendon transfer
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
3.1%
3/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Thermal burn (due to seizure)
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Tonic-clonic seizures exacerbated
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Tonic-clonic seizures increased
|
1.0%
1/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Tooth extraction
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Tooth infection
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/97 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Toxic encephalopathy
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Surgical and medical procedures
Tubal ligation
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Reproductive system and breast disorders
Uterine leiomyoma
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
Other adverse events
| Measure |
Treatment Group (Stimulation ON)
n=97 participants at risk
Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
|
Sham Group (Stimulation OFF)
n=94 participants at risk
Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
6/97 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Adverse drug reaction
|
12.4%
12/97 • Number of events 17 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
19.1%
18/94 • Number of events 26 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Anxiety
|
6.2%
6/97 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
8.5%
8/94 • Number of events 10 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Aphasia
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
4/97 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Back injury
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Back injury (due to seizure)
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
7.4%
7/94 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Balance disorder
|
2.1%
2/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Eye disorders
Blepharospasm
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
5.2%
5/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
7.4%
7/94 • Number of events 11 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Complex partial seizures
|
10.3%
10/97 • Number of events 18 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
14.9%
14/94 • Number of events 17 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Complex partial seizures exacerbated
|
7.2%
7/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
9.6%
9/94 • Number of events 11 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Complex partial seizures increased
|
10.3%
10/97 • Number of events 12 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
13.8%
13/94 • Number of events 17 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Confusional state
|
1.0%
1/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
8.5%
8/94 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Gastrointestinal disorders
Constipation
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Contusion
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
8.5%
8/94 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Contusion (due to seizure)
|
17.5%
17/97 • Number of events 25 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
16.0%
15/94 • Number of events 21 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Depression
|
13.4%
13/97 • Number of events 16 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
14.9%
14/94 • Number of events 15 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Device interaction
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
7.4%
7/94 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Dizziness
|
12.4%
12/97 • Number of events 14 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
13.8%
13/94 • Number of events 15 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Dizziness postural
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Immune system disorders
Drug hypersensitivity
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Dysaesthesia
|
9.3%
9/97 • Number of events 12 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
16.0%
15/94 • Number of events 21 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Dyskinesia
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Ear infection
|
3.1%
3/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Excoriation (due to seizure)
|
9.3%
9/97 • Number of events 18 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Eye disorders
Eye pain
|
3.1%
3/97 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Fatigue
|
11.3%
11/97 • Number of events 11 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.1%
3/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Head injury
|
7.2%
7/97 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
7.4%
7/94 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Head injury (due to seizure)
|
6.2%
6/97 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
10.6%
10/94 • Number of events 11 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Headache
|
21.6%
21/97 • Number of events 28 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
28.7%
27/94 • Number of events 41 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Vascular disorders
Hypertension
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
6/97 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Implant site pain
|
42.3%
41/97 • Number of events 51 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
33.0%
31/94 • Number of events 39 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Implant site paraesthesia
|
5.2%
5/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Implant site swelling
|
5.2%
5/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Incision site infection
|
6.2%
6/97 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
0.00%
0/94 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Influenza
|
13.4%
13/97 • Number of events 17 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
13.8%
13/94 • Number of events 19 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Insomnia
|
8.2%
8/97 • Number of events 10 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
8.5%
8/94 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Joint injury
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Joint injury (due to seizure)
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
9.6%
9/94 • Number of events 10 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Limb injury (due to seizure)
|
3.1%
3/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Memory impairment
|
8.2%
8/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
8.5%
8/94 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Reproductive system and breast disorders
Menstrual disorder
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Migraine
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Monoparesis
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Multiple injuries (due to seizure)
|
4.1%
4/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
6.2%
6/97 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Nasopharyngitis
|
29.9%
29/97 • Number of events 46 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
26.6%
25/94 • Number of events 40 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/97 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.2%
5/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Nystagmus
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
8/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Psychiatric disorders
Panic attack
|
6.2%
6/97 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Paraesthesia
|
4.1%
4/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
8.5%
8/94 • Number of events 10 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Pharyngitis
|
2.1%
2/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Photopsia
|
5.2%
5/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
7.4%
7/94 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Renal and urinary disorders
Polyuria
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Postictal state
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Postoperative constipation
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Procedural headache
|
27.8%
27/97 • Number of events 30 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
28.7%
27/94 • Number of events 27 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
6.2%
6/97 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
General disorders
Pyrexia
|
4.1%
4/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
1.1%
1/94 • Number of events 1 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
6/97 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Sciatica
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Immune system disorders
Seasonal allergy
|
8.2%
8/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures (motor)
|
5.2%
5/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
7.4%
7/94 • Number of events 12 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures (sensory)
|
11.3%
11/97 • Number of events 12 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
10.6%
10/94 • Number of events 14 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures exacerbated (motor)
|
3.1%
3/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures exacerbated (sensory)
|
3.1%
3/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures increased (motor)
|
3.1%
3/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Simple partial seizures increased (sensory)
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Sinusitis
|
4.1%
4/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.2%
5/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
4.3%
4/94 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Skin laceration (due to seizure)
|
18.6%
18/97 • Number of events 31 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
10.6%
10/94 • Number of events 21 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Somnolence
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.2%
5/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
20.6%
20/97 • Number of events 30 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
22.3%
21/94 • Number of events 24 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Thermal burn
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
3/97 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Injury, poisoning and procedural complications
Tongue injury (due to seizure)
|
2.1%
2/97 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Tonic-clonic seizures exacerbated
|
8.2%
8/97 • Number of events 8 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
6.4%
6/94 • Number of events 6 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Tonic-clonic seizures increased
|
5.2%
5/97 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
8.5%
8/94 • Number of events 12 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Tooth infection
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
2.1%
2/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Nervous system disorders
Tremor
|
8.2%
8/97 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
11.7%
11/94 • Number of events 13 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Upper respiratory tract infection
|
15.5%
15/97 • Number of events 19 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
17.0%
16/94 • Number of events 22 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Infections and infestations
Urinary tract infection
|
11.3%
11/97 • Number of events 11 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
7.4%
7/94 • Number of events 9 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
2/97 • Number of events 2 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
3.2%
3/94 • Number of events 3 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Eye disorders
Vision blurred
|
4.1%
4/97 • Number of events 4 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
5.3%
5/94 • Number of events 5 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
6/97 • Number of events 10 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
7.4%
7/94 • Number of events 7 • Initial implant through 2 years post-implant
SAE = a negative change in subject's physical/mental health as experienced by subject or observed by clinician, during any part of the study, that resulted in: * significant risks or consequences to the subject's acute or long-term health * serious injury or death * hospital admission or required invasive medical intervention to alleviate the AE
|
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 and Institution agree that the 1st publication of study results shall be a joint, multi-center publication. 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.
- Publication restrictions are in place
Restriction type: OTHER