Study: NCT01172067

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death; not related to study devices
Frequency: 15 affected / 198 at risk

Adverse event: Hopitalization
Serious: yes
Organ System: Cardiac disorders
Notes: Patient hopitalized then expired; death not related to study devices
Frequency: 3 affected / 198 at risk

Adverse event: Heart Failure Deterioration; Death
Serious: yes
Organ System: Cardiac disorders
Notes: Heart failure deteriorated; patient expired; SAE not related to study devices.
Frequency: 2 affected / 198 at risk

Adverse event: Cardiopulmonary arrest, death
Serious: yes
Organ System: Cardiac disorders
Notes: Patient sustained cardiopulmonary arrest. Patient expired. The death is not related to study devices.
Frequency: 2 affected / 198 at risk

Adverse event: Junctional rhythm, hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Patient sustained junctional rhythm and low blood pressure. The event was considered related to study device. The pace maker was re-interrogated.
Frequency: 1 affected / 198 at risk

Adverse event: Heart failure deterioration, elevated left ventricular pacing threshold
Serious: yes
Organ System: Cardiac disorders
Notes: Heart failure deteriorated. Left ventricular pacing threshold increased. The event is not related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: Heart failure deterioration, myocardial infarction, venous thrombosis, death
Serious: yes
Organ System: Cardiac disorders
Notes: Heart failure deteriorated. Patient sustained myocardial infarction and venous thrombosis. Patient expired. The death is not related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: Chest distress, short breaths
Serious: yes
Organ System: Cardiac disorders
Notes: Patient stated chest distress and short breaths. Patient was hospitalized. The event is not related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: pacemaker pocket ulceration
Serious: yes
Organ System: Cardiac disorders
Notes: Pacemaker pocket skin ulceration. The event is not related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: pacemaker reject
Serious: yes
Organ System: Cardiac disorders
Notes: Patient's body rejected pacemaker. The event is not related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: Phrenic nerve stimulation
Serious: no
Organ System: Cardiac disorders
Notes: Patient experience phrenic nerve stimulation. The event is not related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: Elevated left ventricular pacing threshold
Serious: no
Organ System: Cardiac disorders
Notes: Left ventricular pacing threshold increased.
Frequency: 2 affected / 198 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Cardiac disorders
Notes: Patient sustained coronary sinus dissection; the event is not related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: Right ventricular lead dislocation/displacement
Serious: no
Organ System: Cardiac disorders
Notes: Right ventricular lead dislocation/displacement; the event is not related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: Left ventricular lead dislocation/displacement
Serious: no
Organ System: Cardiac disorders
Notes: Left ventricular lead dislocation/displacement; the event is related to study devices.
Frequency: 1 affected / 198 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death; not related to study devices
Frequency: 13 affected / 194 at risk

Adverse event: Hopitalization
Serious: yes
Organ System: Cardiac disorders
Notes: Patient hopitalized then expired; death not related to study devices
Frequency: 1 affected / 194 at risk

Adverse event: Heart failure deterioration, hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: Heart failure deteriorated. Patient hospitalized. The event is not related to study devices.
Frequency: 1 affected / 194 at risk

Adverse event: Heart failure deterioration, phrenic nerve stimulation
Serious: yes
Organ System: Cardiac disorders
Notes: Heart failure deteriorated. Patient experienced phrenic nerve stimulation. The event was considered related to study devices.
Frequency: 1 affected / 194 at risk

Adverse event: Myocardial ischemia, staged heart bypass surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Patient was diagnosed with myocardial ischemia and underwent staged heart bypass surgery. The event is not related to study devices.
Frequency: 1 affected / 194 at risk

Adverse event: Cerebral hemorrhage, death
Serious: yes
Organ System: Vascular disorders
Notes: Patient sustained cerebral hemorrhage. Patient expired. The death is not related to study devices.
Frequency: 1 affected / 194 at risk

Adverse event: Haematoma, low right atrial lead sensing
Serious: yes
Organ System: Cardiac disorders
Notes: Patient sustained haematoma; the right atrial lead sensing decreased. The event is not related to study devices.
Frequency: 1 affected / 194 at risk

Adverse event: Phrenic nerve stimulation
Serious: no
Organ System: Cardiac disorders
Notes: Patient experience phrenic nerve stimulation. The event is not related to study devices.
Frequency: 2 affected / 194 at risk

Adverse event: Right atrial lead dislocation/displacement
Serious: no
Organ System: Cardiac disorders
Notes: Right atrial lead dislocation/displacement; the event is not related to study devices.
Frequency: 1 affected / 194 at risk

Adverse event: Elevated pacing threshold of left ventricular lead; lead dislocation/displacem
Serious: no
Organ System: Cardiac disorders
Notes: Elevated pacing threshold of left ventricular lead; lead dislocation/displacem; the event is related to study devices.
Frequency: 1 affected / 194 at risk

Adverse event: Infection at pacing system
Serious: no
Organ System: Infections and infestations
Notes: Patient sustain infection at pacing system; the event is not related to study devices.
Frequency: 1 affected / 194 at risk

Adverse event: Anaphylactic shock
Serious: no
Organ System: Immune system disorders
Notes: Patient experienced anaphylactic shock; the event is not related to study devices.
Frequency: 1 affected / 194 at risk