Study: NCT01424722

Adverse event: Aspiration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Battery Depletion at Implant
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2258 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2258 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2258 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2258 at risk

Adverse event: Cardiac/respiratory arrest
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2258 at risk

Adverse event: Coronary sinus perforation/dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2258 at risk

Adverse event: Device infection/erosion
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 2258 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 11 affected / 2258 at risk

Adverse event: Discomfort at implant site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 2258 at risk

Adverse event: Elevated pacing thresholds
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 2258 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 2258 at risk

Adverse event: Generator changeout/upgrade
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2258 at risk

Adverse event: Genitourinary disease/disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 2258 at risk

Adverse event: High Defibrillation Threshold
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2258 at risk

Adverse event: Inappropriate therapy due to non-ventricular rhythm
Serious: yes
Organ System: Product Issues
Frequency: 10 affected / 2258 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 2258 at risk

Adverse event: Lead dislodgment or migration
Serious: yes
Organ System: Product Issues
Frequency: 62 affected / 2258 at risk

Adverse event: Lead entanglement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Lead fracture
Serious: yes
Organ System: Product Issues
Frequency: 13 affected / 2258 at risk

Adverse event: Lead Impedance out of range
Serious: yes
Organ System: Product Issues
Frequency: 13 affected / 2258 at risk

Adverse event: Lead insulation damage
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2258 at risk

Adverse event: Lead noise
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2258 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 2258 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2258 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2258 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 2258 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 2258 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2258 at risk

Adverse event: Upper extremity thromboembolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 2258 at risk

Adverse event: Vascular Injury/Repair
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2258 at risk

Adverse event: Inappropriate therapy due to oversensing
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 2258 at risk

Adverse event: Lead abrasion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2258 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2258 at risk

Adverse event: Vascular disease/disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 2258 at risk

Adverse event: Fluid accumulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Hypertension/hypertensive crisis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Inappropriate therapy due to non-ventricular rhythm
Serious: no
Organ System: Product Issues
Frequency: 46 affected / 2258 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 2258 at risk

Adverse event: Lead Fracture
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 2258 at risk

Adverse event: Lead noise
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2258 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 2258 at risk

Adverse event: Stroke/Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 2258 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 2258 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2258 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2258 at risk

Adverse event: Cardiac perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Chest pain - non cardiac
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Cognitive changes
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Device infection/erosion
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2258 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 2258 at risk

Adverse event: Discomfort at incision/implant site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 2258 at risk

Adverse event: Oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Exercise limitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 2258 at risk

Adverse event: Inappropriate therapy due to oversensing
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 2258 at risk

Adverse event: Lead impedance out of range
Serious: no
Organ System: Product Issues
Frequency: 9 affected / 2258 at risk

Adverse event: Lead insulation damage
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 2258 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 2258 at risk

Adverse event: Musculoskeletal disease/disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Non-SJM hardware related problem
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2258 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 2258 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2258 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2258 at risk

Adverse event: Phantom shock
Serious: no
Organ System: Psychiatric disorders
Notes: Subject imagined shock from device
Frequency: 2 affected / 2258 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2258 at risk

Adverse event: Possible generator migration
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2258 at risk

Adverse event: Skin disease/disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2258 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2258 at risk

Adverse event: Suture protrusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2258 at risk

Adverse event: Syncope/pre-syncope
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2258 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 2258 at risk

Adverse event: Upper extremity thromboembolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2258 at risk