Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-25 @ 12:49 PM
NCT ID:
NCT01596595
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
Study:
NCT01596595
Study Brief:
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| RELIANCE 4-SITE | All-Cause Mortality and Adverse Events are reported for all enrolled subjects (N=1820). | 327 | None | 1017 | 1820 | 980 | 1820 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Other - PG System | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated Threshold - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Tachy Therapy - SVT | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Tachy Therapy - Other | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Early ERI - Premature Declaration | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Pacemaker Mediated Tachycardia (PMT) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Erosion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Infection (> 30 days post implant) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hematoma- Pocket (>30 days post implant) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Migration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post Surgical wound discomfort/bruising/swelling | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post-surgical pocket hemorrhage/bleeding/drainage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post -Surgical infection (≤ 30 days post implant) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Adverse Reaction - Respiratory | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hematoma - pocket (≤ 30 days post-implant) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Thromboembolic events | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure - PG System - Other | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Dislodgement - Unable to Capture - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Multiple signs- RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - No reported signs - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other Lead Related | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Oversensing - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Unable to Capture - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac Stimulation - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Insulation Breach - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Myocardial Perforation post implant- RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Low Out of Range Impedance - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Unable to capture - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Elevated threshold - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Extracardiac stimulation - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Multiple signs - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - No reported signs - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Unable to Capture - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac Stimulation - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Conductor Coil Fracture - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Insulation Breach - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Unable to Capture - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Elevated threshold - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Extracardiac stimulation - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Multiple signs - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - No reported signs - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy - SVT | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hemothorax | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Myocardial perforation without tamponade | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Myocardial perforation with tamponade | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pericardial Effusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure - Lead - Other | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| 3rd Degree AV Block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sinus Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulseless Electrical Activity (PEA) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular Fibrillation (VF) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular Tachycardia (VT)/Monomorphic VT | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Torsades de Pointes | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Nonsustained ventricular tachycardia (NSVT) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Fibrillation (AF) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sinus Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Premature Ventricular Contractions (PVC) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dizziness - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest Pain - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral edema - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary Edema - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fatigue - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Renal Failure/Insufficiency - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dehydration - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Gastrointestinal - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Weight Gain - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart Failure Symptoms - Unspecified | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multiple Heart Failure Symptoms | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypertension - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart Failure Patient Condition - Cardiovascular - OTHER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multi-system Failure - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension/Orthostatic Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypertension/Hypertensive Crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cardiogenic Shock | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Peripheral Vascular Disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Intermittent Claudication | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Aortic Stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Aortic Regurgitation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Mitral Stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Mitral Regurgitation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest Pain - Ischemic | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Chest Pain - Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fatigue/Weakness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Multiple Symptoms | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Patient Condition - Cardiovascular - OTHER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Transient Ischemic Attack (TIA) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cerebrovascular Accident (CVA) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Deep Vein Thrombosis (DVT) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Pulmonary Embolism (PE) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Distal thromboemboli | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Pericardial effusion - unrelated procedure/device | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pericarditis - unrelated procedure/device | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hematoma - unrelated procedure/device | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hemorrhage - unrelated procedure/device | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Patient Condition - Non-Cardiovascular - OTHER | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| System Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fever and/or Virus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Physical Trauma | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abnormal Laboratory Values | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hematological | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neurological | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pulmonary | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Genitourinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Renal | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Psychological | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Integumentary | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Head, eyes, ears, nose, throat (HEENT) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Endocrine | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Multi-System Failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Renal | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Psychological | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Integumentary | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Head, eyes, ears, nose, throat (HEENT) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Endocrine | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Immune | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Oversensing - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Unable to Capture - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other - PG System | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Oversensing - RV 1120 - Undersensing - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated Threshold - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated Threshold - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac Stimulation - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Tachy Therapy - SVT | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Tachy Therapy - Other | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Early ERI - Premature declaration | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Pacemaker Mediated Tachycardia (PMT) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Infection (> 30 days post implant) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Psychological effect due to device therapy | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hematoma- Pocket (>30 days post implant) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Seroma - Pocket (>30 days post implant) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Migration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post Surgical wound discomfort/bruising/swelling | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post-surgical pocket hemorrhage/bleeding/drainage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post -Surgical infection (≤ 30 days post implant) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Adverse Reaction - General | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Adverse Reaction - Respiratory | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Adverse Reaction - Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Adverse Reaction - Hypotension | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Inadvertent VT/VF | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Physical trauma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hematoma - pocket (≤ 30 days post-implant) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Seroma - Pocket (≤ 30 days post implant) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Thromboembolic events | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure - PG System - Other | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Oversensing - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Undersensing - RA 2032 - Unable to Capture - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated Threshold - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac Stimulation - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Conductor Coil Fracture - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| High Out of Range Impedance - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Multiple signs- RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - No reported signs - RA | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other Lead Related | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Oversensing - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Undersensing - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Unable to Capture - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac Stimulation - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Myocardial Perforation post implant- RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Low Out of Range Impedance - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Unable to capture - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Elevated threshold - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Oversensing- RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Multiple signs - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - No reported signs - RV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Unable to Capture - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated Threshold - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac Stimulation - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Low Out of Range Impedance - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - Unable to Capture - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgement - No reported signs - LV | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Unable to Convert | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy - SVT | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy - Noise | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Puncture Site hematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Sinus Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chronotropic Incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular Fibrillation (VF) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular Tachycardia (VT)/Monomorphic VT | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Torsades de Pointes | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Nonsustained ventricular tachycardia (NSVT) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Fibrillation (AF) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sinus Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Premature Ventricular Contractions (PVC) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dizziness - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest Pain - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral edema - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary Edema - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fatigue - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Renal Failure/Insufficiency - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Gastrointestinal - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Weight Gain - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart Failure Symptoms - Unspecified | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multiple Heart Failure Symptoms | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypertension - Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart Failure Patient Condition - Cardiovascular - OTHER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension/Orthostatic Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypertension/Hypertensive Crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Peripheral Vascular Disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Intermittent Claudication | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Aortic Stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Aortic Regurgitation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Mitral Regurgitation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest Pain - Ischemic | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Chest Pain - Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fatigue/Weakness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Patient Condition - Cardiovascular - OTHER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Transient Ischemic Attack (TIA) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cerebrovascular Accident (CVA) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Deep Vein Thrombosis (DVT) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Pulmonary Embolism (PE) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Distal thromboemboli | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Intracardiac thrombus | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pericardial effusion - unrelated procedure/device | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pericarditis - unrelated procedure/device | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hematoma - unrelated procedure/device | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Patient Condition - Non-Cardiovascular - OTHER | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| System Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fever and/or Virus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Physical Trauma | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abnormal Laboratory Values | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hematological | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neurological | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pulmonary | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Genitourinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |