Study: NCT01685047

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 481 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 481 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 481 at risk

Adverse event: Component failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Device component failure
Frequency: 4 affected / 481 at risk

Adverse event: Death - Cardiovascular related
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 481 at risk

Adverse event: Death - Non cardiovascular related
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 481 at risk

Adverse event: Drug Reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 481 at risk

Adverse event: Exacerbation of Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 481 at risk

Adverse event: Gastro-enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 481 at risk

Adverse event: Inappropriate high voltage therapy
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 481 at risk

Adverse event: Infection related to system and/or procedure
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 481 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 481 at risk

Adverse event: Lead dislodgement or migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 481 at risk

Adverse event: Inappropriate device function
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 481 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 481 at risk

Adverse event: Other cardiovascular related event
Serious: yes
Organ System: Vascular disorders
Frequency: 30 affected / 481 at risk

Adverse event: Other non cardiovascular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 61 affected / 481 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 481 at risk

Adverse event: Thromboemboli
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 481 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 481 at risk

Adverse event: Veinthrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 481 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 481 at risk

Adverse event: Exacerbation of heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 481 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 481 at risk

Adverse event: Inappropriate High Voltage therapy
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 481 at risk

Adverse event: Inappropriate low voltage therapy
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 481 at risk

Adverse event: Lead dislodgement or migration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 481 at risk

Adverse event: Other cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 481 at risk

Adverse event: Other non cardiovascular
Serious: no
Organ System: General disorders
Frequency: 14 affected / 481 at risk

Adverse event: device oversensing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 481 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 481 at risk

Adverse event: Device threshold elevation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 481 at risk

Adverse event: Vein thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 481 at risk