Trial Outcomes & Findings for RNS® System LTT Study (NCT NCT00572195)
NCT ID: NCT00572195
Last Updated: 2019-06-26
Results Overview
The number of subjects having an SAE during the RNS® System LTT study.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
230 participants
Primary outcome timeframe
2 years post-implant through 9 years post-implant (7 years)
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
Evaluation Group (Stimulation ON)
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Overall Study
STARTED
|
230
|
|
Overall Study
COMPLETED
|
162
|
|
Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
| Measure |
Evaluation Group (Stimulation ON)
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
50
|
|
Overall Study
Death
|
9
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Evaluation Group (Stimulation ON)
n=230 Participants
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=230 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
223 Participants
n=230 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=230 Participants
|
|
Age, Continuous
|
34.2 Years
STANDARD_DEVIATION 11.4 • n=230 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=230 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=230 Participants
|
|
Region of Enrollment
United States
|
230 participants
n=230 Participants
|
PRIMARY outcome
Timeframe: 2 years post-implant through 9 years post-implant (7 years)The number of subjects having an SAE during the RNS® System LTT study.
Outcome measures
| Measure |
Evaluation Group (Stimulation ON)
n=230 Participants
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAE)
|
177 Participants
|
PRIMARY outcome
Timeframe: 6 months post-implant through 9 years post-implant (8.5 years)Population: N represents the number of subjects who have data during that period.
The average percentage change in the mean frequency of total disabling seizures relative to pre-implant baseline. The percent change will be calculated for each subject over 6-month intervals beginning 6 months after RNS® System implant and continuing through completion of the RNS® System LTT study.
Outcome measures
| Measure |
Evaluation Group (Stimulation ON)
n=230 Participants
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Percentage Change From Baseline in Seizure Frequency
6-12 Months
|
-31.5 Percentage of Change
Interval -62.4 to -5.0
|
|
Percentage Change From Baseline in Seizure Frequency
12-18 Months
|
-46.2 Percentage of Change
Interval -72.3 to -15.1
|
|
Percentage Change From Baseline in Seizure Frequency
18-24 Months
|
-46.7 Percentage of Change
Interval -74.9 to -16.1
|
|
Percentage Change From Baseline in Seizure Frequency
24-30 Months
|
-50.3 Percentage of Change
Interval -79.2 to -16.9
|
|
Percentage Change From Baseline in Seizure Frequency
30-36 Months
|
-58.3 Percentage of Change
Interval -83.3 to -21.6
|
|
Percentage Change From Baseline in Seizure Frequency
36-42 Months
|
-61.1 Percentage of Change
Interval -84.9 to -27.8
|
|
Percentage Change From Baseline in Seizure Frequency
42-48 Months
|
-61.7 Percentage of Change
Interval -87.6 to -27.7
|
|
Percentage Change From Baseline in Seizure Frequency
48-54 Months
|
-60.5 Percentage of Change
Interval -85.2 to -22.0
|
|
Percentage Change From Baseline in Seizure Frequency
54-60 Months
|
-63.1 Percentage of Change
Interval -90.7 to -23.5
|
|
Percentage Change From Baseline in Seizure Frequency
60-66 Months
|
-65.4 Percentage of Change
Interval -92.7 to -23.7
|
|
Percentage Change From Baseline in Seizure Frequency
66-72 Months
|
-67.7 Percentage of Change
Interval -93.8 to -36.2
|
|
Percentage Change From Baseline in Seizure Frequency
72-78 Months
|
-71.0 Percentage of Change
Interval -95.5 to -29.4
|
|
Percentage Change From Baseline in Seizure Frequency
78-84 Months
|
-72.8 Percentage of Change
Interval -95.4 to -27.7
|
|
Percentage Change From Baseline in Seizure Frequency
84-90 Months
|
-69.7 Percentage of Change
Interval -94.6 to -30.4
|
|
Percentage Change From Baseline in Seizure Frequency
90-96 Months
|
-73.1 Percentage of Change
Interval -94.4 to -38.7
|
|
Percentage Change From Baseline in Seizure Frequency
96-102 Months
|
-72.1 Percentage of Change
Interval -96.1 to -41.3
|
|
Percentage Change From Baseline in Seizure Frequency
102-108 Months
|
-74.5 Percentage of Change
Interval -97.5 to -43.2
|
|
Percentage Change From Baseline in Seizure Frequency
108-114 Months
|
-85.9 Percentage of Change
Interval -100.0 to -43.9
|
|
Percentage Change From Baseline in Seizure Frequency
114-120 Months
|
-77.7 Percentage of Change
Interval -100.0 to -42.7
|
|
Percentage Change From Baseline in Seizure Frequency
120-126 Months
|
-94.1 Percentage of Change
Interval -100.0 to -51.1
|
|
Percentage Change From Baseline in Seizure Frequency
126-132 Months
|
-86.1 Percentage of Change
Interval -100.0 to -53.8
|
|
Percentage Change From Baseline in Seizure Frequency
132-138 Months
|
-95.7 Percentage of Change
Interval -100.0 to -91.5
|
SECONDARY outcome
Timeframe: 6 months post-implant through 9 years post-implant (8.5 years)Population: N represents the number of subjects who have data during that period.
The proportion of subjects with greater than or equal to 50% reduction in total disabling seizures compared to pre-implant baseline.
Outcome measures
| Measure |
Evaluation Group (Stimulation ON)
n=230 Participants
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Responder Rate
6-12 Months
|
33.2 Percentage of patients
Interval 27.4 to 39.5
|
|
Responder Rate
12-18 Months
|
46.7 Percentage of patients
Interval 40.4 to 53.2
|
|
Responder Rate
18-24 Months
|
47.6 Percentage of patients
Interval 41.2 to 54.1
|
|
Responder Rate
24-30 Months
|
50.2 Percentage of patients
Interval 43.7 to 56.7
|
|
Responder Rate
30-36 Months
|
56.4 Percentage of patients
Interval 49.8 to 62.8
|
|
Responder Rate
36-42 Months
|
57.8 Percentage of patients
Interval 51.2 to 64.2
|
|
Responder Rate
42-48 Months
|
61.2 Percentage of patients
Interval 54.5 to 67.6
|
|
Responder Rate
48-54 Months
|
60.2 Percentage of patients
Interval 53.3 to 66.7
|
|
Responder Rate
54-60 Months
|
61.1 Percentage of patients
Interval 54.2 to 67.6
|
|
Responder Rate
60-66 Months
|
58.4 Percentage of patients
Interval 51.3 to 65.2
|
|
Responder Rate
66-72 Months
|
67.0 Percentage of patients
Interval 60.0 to 73.4
|
|
Responder Rate
72-78 Months
|
66.9 Percentage of patients
Interval 59.7 to 73.3
|
|
Responder Rate
78-84 Months
|
65.7 Percentage of patients
Interval 58.5 to 72.3
|
|
Responder Rate
84-90 Months
|
64.9 Percentage of patients
Interval 57.5 to 71.7
|
|
Responder Rate
90-96 Months
|
70.2 Percentage of patients
Interval 62.9 to 76.5
|
|
Responder Rate
96-102 Months
|
68.5 Percentage of patients
Interval 61.1 to 75.0
|
|
Responder Rate
102-108 Months
|
70.9 Percentage of patients
Interval 63.4 to 77.4
|
|
Responder Rate
108-114 Months
|
74.5 Percentage of patients
Interval 65.7 to 81.8
|
|
Responder Rate
114-120 Months
|
66.7 Percentage of patients
Interval 48.8 to 80.8
|
|
Responder Rate
120-126 Months
|
75.0 Percentage of patients
Interval 46.8 to 91.1
|
|
Responder Rate
126-132 Months
|
83.3 Percentage of patients
Interval 43.6 to 97.0
|
|
Responder Rate
132-138 Months
|
100.0 Percentage of patients
Interval 34.2 to 100.0
|
SECONDARY outcome
Timeframe: 1 year post-implant through 9 years post-implant (8 years)Population: N represents the number of subjects who have data during that period.
QOLIE 89 (for English-speaking subjects) or QOLIE 31 P (for Spanish speaking subjects) scores collected at each year of follow-up after implantation of the RNS® System compared to the QOLIE 89 / QOLIE 31 P at pre-implant baseline. A QOLIE overall score was obtained using a weighted average of multi-item scale scores. The QOLIE overall score was converted to a T-score, a normally distributed scale with a mean score of 50 and standard deviation (SD) of 10. Higher scores reflect a better quality of life.
Outcome measures
| Measure |
Evaluation Group (Stimulation ON)
n=230 Participants
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
QOLIE (Quality of Life in Epilepsy)
Baseline
|
46.1 Score on a scale
Standard Deviation 9.7
|
|
QOLIE (Quality of Life in Epilepsy)
Year 1
|
49.2 Score on a scale
Standard Deviation 10.5
|
|
QOLIE (Quality of Life in Epilepsy)
Year 2
|
49.3 Score on a scale
Standard Deviation 10.3
|
|
QOLIE (Quality of Life in Epilepsy)
Year 3
|
48.8 Score on a scale
Standard Deviation 10.4
|
|
QOLIE (Quality of Life in Epilepsy)
Year 4
|
48.1 Score on a scale
Standard Deviation 10.6
|
|
QOLIE (Quality of Life in Epilepsy)
Year 5
|
48.4 Score on a scale
Standard Deviation 10.9
|
|
QOLIE (Quality of Life in Epilepsy)
Year 6
|
48.4 Score on a scale
Standard Deviation 11.7
|
|
QOLIE (Quality of Life in Epilepsy)
Year 7
|
47.4 Score on a scale
Standard Deviation 11.0
|
|
QOLIE (Quality of Life in Epilepsy)
Year 8
|
47.9 Score on a scale
Standard Deviation 11.3
|
|
QOLIE (Quality of Life in Epilepsy)
Year 9
|
47.2 Score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 6 months post-implant through 9 years post-implant (8.5 years)Population: N represents the number of subjects who have data during that period.
The rate of occurrence of any adverse event (AE) observed during the Long-term Treatment Investigation.
Outcome measures
| Measure |
Evaluation Group (Stimulation ON)
n=230 Participants
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Adverse Event Rate
|
228 Participants
|
Adverse Events
Evaluation Group (Stimulation ON)
Serious events: 177 serious events
Other events: 228 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Evaluation Group (Stimulation ON)
n=230 participants at risk
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Investigations
EEG monitoring
|
19.1%
44/230 • Number of events 63 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Implant site infection
|
11.3%
26/230 • Number of events 29 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
8.3%
19/230 • Number of events 22 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Tonic-clonic seizures increased
|
5.2%
12/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Brain lobectomy
|
4.8%
11/230 • Number of events 12 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Complex partial seizures increased
|
4.3%
10/230 • Number of events 13 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Death
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Medical device removal
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Pneumonia
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Convulsive status epilepticus
|
3.5%
8/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Implant site erosion
|
3.5%
8/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Hospitalisation
|
3.0%
7/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Suicide attempt
|
2.6%
6/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Depression suicidal
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Postictal state
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Adverse drug reaction
|
2.2%
5/230 • Number of events 5 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Psychotic disorder
|
2.2%
5/230 • Number of events 5 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Device lead damage
|
2.2%
5/230 • Number of events 5 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Investigations
Medical observation
|
2.2%
5/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Nonconvulsive status epilepticus
|
2.2%
5/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.2%
5/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Tonic-clonic seizures exacerbated
|
2.2%
5/230 • Number of events 5 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Product Issues
Live birth
|
1.7%
4/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Hernia
|
1.7%
4/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Complex partial seizures exacerbated
|
1.7%
4/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.7%
4/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
4/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Investigations
Angiogram cerebral
|
1.7%
4/230 • Number of events 5 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Device lead revision
|
1.7%
4/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Urinary tract infection
|
1.7%
4/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture (dts)
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Investigations
Investigation
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Skin laceration (dts)
|
1.3%
3/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Depression
|
1.3%
3/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Non-cardiac chest pain
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Hepatobiliary disorders
Cholecystitis
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.3%
3/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.3%
3/230 • Number of events 4 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Migraine
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Cranioplasty
|
1.3%
3/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Acute psychosis
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Appendicitis
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Breast cosmetic surgery
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Immune system disorders
Drug hypersensitivity
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Head injury (dts)
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Headache
|
0.87%
2/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Hip fracture (dts)
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Intracranial hypotension
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Jaw fracture (dts)
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Paraesthesia
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Postictal paralysis
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Road traffic accident (dts)
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Status epilepticus
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Subdural haematoma (dts)
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Suicidal ideation
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Thermal burn (dts)
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage (dts)
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.87%
2/230 • Number of events 3 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Implant site infection (dts)
|
0.87%
2/230 • Number of events 2 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Tracheostomy
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Renal and urinary disorders
Urinary retention
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Vasectomy reversal
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Social circumstances
Victim of crime
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Viral infection
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Wrist fracture (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Premature battery depletion (GB-2570)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Premature battery depletion (RE-CR2450N)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Device protrusion
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Device electrical finding
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Implant site discharge
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Facial paresis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Complex partial seizures
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Agitation
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Stitch abscess
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Simple partial seizures increased (sensory)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Incision site cellulitis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Intraventricular haemorrhage (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Lower limb fracture (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Investigations
Lumbar puncture
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Medical device implantation (LR)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Medical device removal (LR)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Memory impairment
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Menicus lesion
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic melanoma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Neuralgia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Neuromyelitis optica
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Neutropenic infection
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Paraparesis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Reproductive system and breast disorders
Pelvic congestion
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Pelvic fracture (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Pilonidal cyst
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Investigations
Platelet count decreased
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Pyelonephritis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Radiculopathy
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Rectal discharge
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma state unspecified
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Sepsis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Seroma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Simple partial seizures increased (motor)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Skeletal injury (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Somatic delusion
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Spinal fracture (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Vascular disorders
Subarachnoid haemorrhage (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Submandibular mass
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Suicidal behavior
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Syncope
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Tonic-clonic seizures
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Tonsillitis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Tooth extraction
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Tooth impacted
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Tooth infection
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Toothache
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal obstruction
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Abdominal sepsis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Abnormal behaviour
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Blood and lymphatic system disorders
Acute myeloid leukaemia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Alcohol abuse
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Ankle fracture (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Investigations
Anticonvulsant drug level below therapeutic
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Anxiety
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Aphasia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Cardiac disorders
Arrhthmia supraventricular
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Vascular disorders
Arteriovenous fistula
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Ataxia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Cardiac disorders
Atrial flutter
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Reproductive system and breast disorders
Breast mass
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Breast reconstruction
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Cardiac disorders
Cardiac syncope
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Reproductive system and breast disorders
Cervical cyst
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Chest pain
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Clavicle fracture (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Colostomy
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Confusional state
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Contusion (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Conversion disorders
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Diverticulitis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Dizziness
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Drug dependence
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Drug withdrawal headache
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Dyskinesia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Ear infection
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Endodontic procedure
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Epileptic psychosis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Face injury (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Facial bones fracture (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Fall (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Fatigue
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Feeling cold
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Fractured skull depressed
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrinoma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Gastroenteritis viral
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Renal and urinary disorders
Haematuria
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Hand fracture (dts)
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Vascular disorders
Hypertension
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Metabolism and nutrition disorders
Hypoglycaemic coma
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.43%
1/230 • Number of events 1 • 6 months post-implant through 9 years post-implant (8.5 years)
|
Other adverse events
| Measure |
Evaluation Group (Stimulation ON)
n=230 participants at risk
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
|
|---|---|
|
Nervous system disorders
Complex partial seizures exacerbated
|
7.0%
16/230 • Number of events 20 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Procedural headache
|
7.0%
16/230 • Number of events 16 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Multiple injuries (dts)
|
7.0%
16/230 • Number of events 38 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
50.0%
115/230 • Number of events 226 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Adverse drug reaction
|
30.9%
71/230 • Number of events 113 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Implant site pain
|
30.0%
69/230 • Number of events 103 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Investigations
EEG monitoring
|
19.1%
44/230 • Number of events 64 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Nasopharyngitis
|
18.3%
42/230 • Number of events 63 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Skin laceration (dts)
|
17.8%
41/230 • Number of events 81 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Headache
|
17.4%
40/230 • Number of events 51 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Influenza
|
14.3%
33/230 • Number of events 40 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Contusion (dts)
|
13.5%
31/230 • Number of events 65 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
30/230 • Number of events 40 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Implant site infection
|
12.6%
29/230 • Number of events 34 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Urinary tract infection
|
12.6%
29/230 • Number of events 42 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Depression
|
12.2%
28/230 • Number of events 30 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Complex partial seizures increased
|
10.9%
25/230 • Number of events 40 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Sinusitis
|
10.9%
25/230 • Number of events 30 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Procedural pain
|
10.4%
24/230 • Number of events 27 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Joint injury
|
9.6%
22/230 • Number of events 26 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
22/230 • Number of events 29 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
9.1%
21/230 • Number of events 25 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Tonic-clonic seizures increased
|
8.7%
20/230 • Number of events 25 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
18/230 • Number of events 19 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
18/230 • Number of events 20 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Investigations
Vitamin D abnormal
|
7.8%
18/230 • Number of events 18 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Joint injury (dts)
|
7.8%
18/230 • Number of events 24 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
17/230 • Number of events 19 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Tonic-clonic seizures exacerbated
|
7.4%
17/230 • Number of events 19 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Head injury (dts)
|
7.4%
17/230 • Number of events 25 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Insomnia
|
7.0%
16/230 • Number of events 18 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Simple partial seizures (motor)
|
6.5%
15/230 • Number of events 22 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Postictal state
|
6.5%
15/230 • Number of events 15 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Immune system disorders
Drug hypersensitivity
|
6.1%
14/230 • Number of events 18 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Immune system disorders
Seasonal allergy
|
6.1%
14/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
14/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Vascular disorders
Hypertension
|
6.1%
14/230 • Number of events 15 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
13/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Anxiety
|
5.7%
13/230 • Number of events 13 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Complex partial seizures
|
5.7%
13/230 • Number of events 22 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
5.7%
13/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.7%
13/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Gastroenteritis
|
5.7%
13/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Head injury
|
5.7%
13/230 • Number of events 16 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Pneumonia
|
5.7%
13/230 • Number of events 16 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
5.7%
13/230 • Number of events 16 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
13/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
12/230 • Number of events 13 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Paraesthesia
|
5.2%
12/230 • Number of events 12 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.2%
12/230 • Number of events 17 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Brain lobectomy
|
4.8%
11/230 • Number of events 12 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Dizziness
|
4.8%
11/230 • Number of events 12 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Ear infection
|
4.8%
11/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Temor
|
4.8%
11/230 • Number of events 12 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Photopsia
|
4.8%
11/230 • Number of events 15 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Simple partial seizures (sensory)
|
4.8%
11/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Memory impairment
|
4.8%
11/230 • Number of events 12 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Constipation
|
4.3%
10/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.3%
10/230 • Number of events 13 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Excoriation (dts)
|
4.3%
10/230 • Number of events 35 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Dysaesthesia
|
4.3%
10/230 • Number of events 11 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Agitation
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Death
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Fall (dts)
|
3.9%
9/230 • Number of events 14 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Tooth infection
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Medical device removal
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Migraine
|
3.9%
9/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Thermal burn (dts)
|
3.9%
9/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Limb injury
|
3.9%
9/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Convulsive status epilepticus
|
3.5%
8/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Hypoaesthesia
|
3.5%
8/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Implant site erosion
|
3.5%
8/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Limb injury (dts)
|
3.5%
8/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Toothache
|
3.5%
8/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
8/230 • Number of events 8 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Infections and infestations
Pharyngitis
|
3.5%
8/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Simple partial seizures increased (sensory)
|
3.5%
8/230 • Number of events 10 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Non-cardiac chest pain
|
3.5%
8/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Depression suicidal
|
3.0%
7/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Device interaction
|
3.0%
7/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.0%
7/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Hospitalisation
|
3.0%
7/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Surgical and medical procedures
Tooth extraction
|
3.0%
7/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Nonconvulsive status epilepticus
|
3.0%
7/230 • Number of events 11 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Psychotic disorder
|
3.0%
7/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Syncope
|
3.0%
7/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Immune system disorders
Hypersensitivity
|
3.0%
7/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Eye disorders
Vision blurred
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Clavicle fracture (dts)
|
2.6%
6/230 • Number of events 8 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Conversion disorders
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Fatigue
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Hernia
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Oedema peripheral
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.6%
6/230 • Number of events 8 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Injury, poisoning and procedural complications
Road traffic accident (dts)
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Simple partial seizures increased (motor)
|
2.6%
6/230 • Number of events 9 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Nervous system disorders
Sleep apnea
|
2.6%
6/230 • Number of events 6 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
Psychiatric disorders
Suicide attempt
|
2.6%
6/230 • Number of events 8 • 6 months post-implant through 9 years post-implant (8.5 years)
|
|
General disorders
Chest pain
|
2.6%
6/230 • Number of events 7 • 6 months post-implant through 9 years post-implant (8.5 years)
|
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