Study: NCT01733368

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 198 at risk

Adverse event: Atrial or Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 198 at risk

Adverse event: Bleeding/Hematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 198 at risk

Adverse event: Cardiac arrest and death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 198 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 198 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 198 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 198 at risk

Adverse event: Exacerbacion of Heart Failulre
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 198 at risk

Adverse event: Exacerbacion of Heart Failulre and Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 198 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 198 at risk

Adverse event: Musculoskeletal non-cardiac chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 198 at risk

Adverse event: Myocardial infartion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 198 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 198 at risk

Adverse event: Rhabdomyolysis due to amiodarone and statins treatment
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 198 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 198 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Elevated Pacing Thresholds
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 198 at risk

Adverse event: Infection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 198 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 10 affected / 198 at risk

Adverse event: Phrenic Nerve/Diaphragmatic/Extracardiac stimulation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 198 at risk

Adverse event: Sepsis and Death
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Upgrade of the device to DDD by adding atrial lead
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Shiver and physical discomfort during implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Bleeding/Hematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 198 at risk

Adverse event: Hypercapnia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Inappropriate ATP
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 198 at risk

Adverse event: Nause and vomiting
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Pain in the implant site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: phrenic nerve/diaphragmatic/extracardiac stimulation
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 198 at risk