Study: NCT01441583

Adverse event: PG - Oversensing - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 136 at risk

Adverse event: PG - Infection (> 30 days post-implant)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 136 at risk

Adverse event: Procedure - Venous occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 136 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Renal failure due to contrast media - Procedure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 136 at risk

Adverse event: LV - difficult visualization
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Dislodgment - RA
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 136 at risk

Adverse event: Dislodgment - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 136 at risk

Adverse event: Extracardiac stimulation - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 36 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 136 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 136 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 136 at risk

Adverse event: Atrial Arrhythmias (Heart Failure related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 136 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other SVT
Serious: yes
Organ System: Cardiac disorders
Notes: AVRT, AVNRT, EAT etc.
Frequency: 1 affected / 136 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 136 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Adverse Drug Effect
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Multiple symptoms
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Death
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 136 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 136 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 136 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 136 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 136 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 136 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 136 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Immune
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 136 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Extracardiac stimulation - LV
Serious: no
Organ System: Product Issues
Notes: Extracardiac stimulation - LV, only applicable to LV leads. CRT-P subjects have LV leads implanted, Pacemaker subjects do not have LV leads implanted.
Frequency: 11 affected / 36 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 136 at risk