Trial Outcomes & Findings for External Ventricular Drainage Post-Market Clinical Follow-up Registry (NCT NCT05652296)
NCT ID: NCT05652296
Last Updated: 2026-01-28
Results Overview
Percentage of subjects with anticipated drainage (i.e., observed drainage consistent with the patient's clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer required.
Recruitment status
COMPLETED
Target enrollment
120 participants
Primary outcome timeframe
1 month following device implantation
Results posted on
2026-01-28
Participant Flow
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France.
A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
Participant milestones
| Measure |
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
|
|---|---|
|
Overall Study
STARTED
|
117
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
n=117 Participants
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
|
|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 18.49 • n=117 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=117 Participants
|
|
Region of Enrollment
Belgium
|
79 participants
n=117 Participants
|
|
Region of Enrollment
France
|
38 participants
n=117 Participants
|
PRIMARY outcome
Timeframe: 1 month following device implantationPopulation: Subject underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories.
Percentage of subjects with anticipated drainage (i.e., observed drainage consistent with the patient's clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer required.
Outcome measures
| Measure |
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
n=117 Participants
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
|
|---|---|
|
Anticipated Drainage of Cerebrospinal Fluid (CSF)
|
116 Participants
|
SECONDARY outcome
Timeframe: 1 month following device implantationPercentage of subjects in whom the CODMAN Cranial Access Kit, when used with appropriate accessories, provided successful access to the intracranial space.
Outcome measures
| Measure |
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
n=117 Participants
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
|
|---|---|
|
Success of the Access to the Intracranial Space
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month following device implantationPopulation: Subject underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories.
Percentage of subjects with device related adverse events (AEs) during the use of the device in the patient
Outcome measures
| Measure |
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
n=117 Participants
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
|
|---|---|
|
Device- or Procedure Related Adverse Events (AEs) During the Use of the Device in the Patient
|
81 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month following device implantationPopulation: Subject underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories.
Percentage of subjects with noted Device Deficiencies during use of the device such as malfunction, use errors, or other issues related to the performance or safety of the External Ventricular Drainage Systems and Accessories
Outcome measures
| Measure |
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
n=117 Participants
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
|
|---|---|
|
Noted Device Deficiencies During Use of the Device Such as Malfunction, Use Errors, or Other Issues Related to the Performance or Safety of the External Ventricular Drainage Systems and Accessories
|
1 Participants
|
Adverse Events
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
Serious events: 59 serious events
Other events: 54 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
n=117 participants at risk
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
3/117 • Number of events 4 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Cardiac disorders
Cardiac failure
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Cardiac disorders
Cardiac tamponade
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Gastrointestinal disorders
Colitis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Brain death
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Condition aggravated
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Oedema
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Pyrexia
|
1.7%
2/117 • Number of events 3 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Bacteraemia
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Bacterial infection
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
CNS ventriculitis
|
4.3%
5/117 • Number of events 5 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Device related sepsis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Meningitis
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Pneumonia
|
2.6%
3/117 • Number of events 3 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Postoperative wound infection
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Sepsis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Staphylococcal infection
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Urinary tract infection
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Investigations
Bacterial test positive
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Investigations
CSF cell count increased
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Investigations
CSF volume increased
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Metabolism and nutrition disorders
Cerebral salt-wasting syndrome
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Brain injury
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Brain oedema
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Cerebellar haematoma
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Cerebral vasoconstriction
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
5.1%
6/117 • Number of events 8 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Epilepsy
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Headache
|
3.4%
4/117 • Number of events 5 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Hydrocephalus
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Intracranial pressure increased
|
5.1%
6/117 • Number of events 7 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Loss of consciousness
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Speech disorder
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Product Issues
Device dislocation
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Product Issues
Device leakage
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Product Issues
Device occlusion
|
6.0%
7/117 • Number of events 8 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Product Issues
Product contamination
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
2.6%
3/117 • Number of events 3 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
15.4%
18/117 • Number of events 20 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Surgical and medical procedures
Wound drainage
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Surgical and medical procedures
Surgery
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Haematoma
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Hypertension
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Hypotension
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Shock haemorrhagic
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Vasospasm
|
10.3%
12/117 • Number of events 12 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
Other adverse events
| Measure |
Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie.
n=117 participants at risk
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
|
|---|---|
|
Infections and infestations
Nosocomial infection
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Cardiac disorders
Atrial fibrillation
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Cardiac disorders
Tachycardia
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Ear and labyrinth disorders
Ear swelling
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Ear and labyrinth disorders
Haematotympanum
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Ear and labyrinth disorders
Vertigo
|
3.4%
4/117 • Number of events 5 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Endocrine disorders
Hypothyroidism
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Gastrointestinal disorders
Colitis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Gastrointestinal disorders
Constipation
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Gastrointestinal disorders
Nausea
|
6.8%
8/117 • Number of events 12 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
5/117 • Number of events 8 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Asthenia
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Complication associated with device
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Fatigue
|
2.6%
3/117 • Number of events 3 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
General disorders
Pyrexia
|
12.0%
14/117 • Number of events 17 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Bacteraemia
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
CNS ventriculitis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Diverticulitis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Erysipelas
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Pneumonia
|
3.4%
4/117 • Number of events 4 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Pneumonia aspiration
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
3/117 • Number of events 3 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
6.0%
7/117 • Number of events 7 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Cognitive disorder
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Dizziness
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Headache
|
12.8%
15/117 • Number of events 24 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Intracranial pressure increased
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Partial seizures
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Somnolence
|
3.4%
4/117 • Number of events 4 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Status epilepticus
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Subdural hygroma
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Nervous system disorders
Syncope
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Product Issues
Device dislocation
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Product Issues
Device occlusion
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Product Issues
Product contamination
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Psychiatric disorders
Agitation
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Psychiatric disorders
Confusional state
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Psychiatric disorders
Disorientation
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.4%
4/117 • Number of events 4 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Deep vein thrombosis
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Hypertension
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Hypotension
|
0.85%
1/117 • Number of events 1 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
|
Vascular disorders
Vasospasm
|
1.7%
2/117 • Number of events 2 • Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place