Study: NCT01074034

Adverse event: Adverse reaction - General
Serious: yes
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 211 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 211 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 211 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 211 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 211 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 211 at risk

Adverse event: Dislodgment - Elevated threshold - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Dislodgment - Unable to capture - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 211 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 211 at risk

Adverse event: Early ERI - Random component failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 2 affected / 211 at risk

Adverse event: Extracardiac stimulation - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 5 affected / 211 at risk

Adverse event: Guidewire removal- femoral vein
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 211 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: Eye disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 1 affected / 211 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 1 affected / 211 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 2 affected / 211 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Latching
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 211 at risk

Adverse event: Migration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 211 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 7 affected / 211 at risk

Adverse event: Multiple symptoms
Serious: yes
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 2 affected / 211 at risk

Adverse event: Multi-system failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 1 affected / 211 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 3 affected / 211 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Peripheral edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 211 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 1 affected / 211 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 2 affected / 211 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Renal insufficiency - Heart failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 211 at risk

Adverse event: Seroma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 211 at risk