Study: NCT00336284

Adverse event: Ablation procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 977 at risk

Adverse event: Cardiac related hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 45 affected / 977 at risk

Adverse event: Catheterization/PCI procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 15 affected / 977 at risk

Adverse event: Coronary artery bypass graft procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 977 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 52 affected / 977 at risk

Adverse event: Device change-out
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 977 at risk

Adverse event: Device revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 17 affected / 977 at risk

Adverse event: Heart transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 977 at risk

Adverse event: IVC filter implanted
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 977 at risk

Adverse event: LV assist device implanted
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 977 at risk

Adverse event: Lead revision/explant/replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 977 at risk

Adverse event: Non-cardiac related hospitalizations
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 977 at risk

Adverse event: Non-cardiac surgical interventions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 977 at risk

Adverse event: Permacath for dialysis and endoscopy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 977 at risk

Adverse event: Ablation procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 473 at risk

Adverse event: Aborted upgrade procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 473 at risk

Adverse event: Cardiac related hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 473 at risk

Adverse event: Catheterization/PCI procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 473 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 26 affected / 473 at risk

Adverse event: Device change-out
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 473 at risk

Adverse event: Device revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 473 at risk

Adverse event: Lead revision/explant/replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 473 at risk

Adverse event: Non-cardiac related hospitalizations
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 473 at risk

Adverse event: Non-cardiac surgical interventions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 473 at risk

Adverse event: Tighten loose set screw
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 473 at risk