Study: NCT00158925

Adverse event: Unable to capture-LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 96 at risk

Adverse event: Impedance>2000 Ohms LV lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Dislodgment-no reported signs-LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Dislodgment-multiple signs-LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Dislodgment-Unable to capture-LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 96 at risk

Adverse event: Extracardiac stimulation-RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Infection (>30 days post implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 96 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Post-up urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 96 at risk

Adverse event: Elevated blood glucose
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 96 at risk

Adverse event: Hemorrhage-procedural related
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 96 at risk

Adverse event: Migration
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Thromboembolic events
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 96 at risk

Adverse event: Dehiscence of incision over PG
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 96 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 96 at risk

Adverse event: Post-surgical infection (<30 days post-implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 96 at risk

Adverse event: Pneumothorax-procedure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Hematoma-pocket
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 96 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 96 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 96 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 96 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Inadvertent VT/VF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: General adverse reaction
Serious: yes
Organ System: General disorders
Notes: These adverse events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 8 affected / 96 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 96 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 96 at risk

Adverse event: Post-surgical wound-discomfort
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 96 at risk

Adverse event: Phrenic nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Low cardiac output
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pleuritic chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 96 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 96 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 96 at risk

Adverse event: Heart failure symptoms-unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 96 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 96 at risk

Adverse event: Atelactasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Impedance > 2000 Ohms-RV lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 96 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 96 at risk

Adverse event: Unable to capture- non RA lead related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 96 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 96 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 96 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 96 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 96 at risk

Adverse event: Chest pain-ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 96 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Abnormal lab values
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 96 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 96 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 96 at risk

Adverse event: Tooth extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 96 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Distal thromboemboli
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pulmonary symtpoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 96 at risk

Adverse event: General adverse event
Serious: no
Organ System: General disorders
Notes: Adverse events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency: 11 affected / 96 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 96 at risk

Adverse event: Extracardiac stimulation-LV lead
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 96 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 96 at risk

Adverse event: Inappropriate tachy therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 96 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 96 at risk

Adverse event: Pulmonary adverse events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 96 at risk