Study: NCT01528150

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 466 at risk

Adverse event: Cardiac/Venous Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 466 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 466 at risk

Adverse event: Exacerbation of Diabetes
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 466 at risk

Adverse event: Exacerbation of heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 466 at risk

Adverse event: Helix issue
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 466 at risk

Adverse event: hematoma/bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 466 at risk

Adverse event: Impedance out of range
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 466 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 466 at risk

Adverse event: lead dislodgement or migration
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 466 at risk

Adverse event: Muskuloskeletal event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 466 at risk

Adverse event: Lead replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 466 at risk

Adverse event: neoplastic disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 466 at risk

Adverse event: neurological event
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 466 at risk

Adverse event: other various
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 466 at risk

Adverse event: Other Cardiac/cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 466 at risk

Adverse event: Other lead related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 466 at risk

Adverse event: Pneumothorax/hemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 466 at risk

Adverse event: Pulmonary events
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 466 at risk

Adverse event: renal event
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 466 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 466 at risk

Adverse event: Decreased right ventricular sensing
Serious: no
Organ System: Investigations
Frequency: 1 affected / 466 at risk

Adverse event: device programming
Serious: no
Organ System: Investigations
Frequency: 2 affected / 466 at risk

Adverse event: exacerbation of heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 466 at risk

Adverse event: hematoma/bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 466 at risk

Adverse event: impedance out of range
Serious: no
Organ System: Investigations
Frequency: 2 affected / 466 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 466 at risk

Adverse event: lead noise
Serious: no
Organ System: Investigations
Frequency: 3 affected / 466 at risk

Adverse event: musculoskeletal event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 466 at risk

Adverse event: neurological event
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 466 at risk

Adverse event: other various
Serious: no
Organ System: Investigations
Frequency: 13 affected / 466 at risk

Adverse event: other cardio/cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 466 at risk

Adverse event: Other lead related
Serious: no
Organ System: Investigations
Frequency: 1 affected / 466 at risk

Adverse event: Pacemaker software issue
Serious: no
Organ System: Investigations
Frequency: 1 affected / 466 at risk

Adverse event: pulmonary event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 466 at risk