Study: NCT01805154

Adverse event: Acute CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 70 affected / 1524 at risk

Adverse event: Atrial Arrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1524 at risk

Adverse event: Atrial Fib Ablation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1524 at risk

Adverse event: Air embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1524 at risk

Adverse event: Arrest Cardiopulmonary
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1524 at risk

Adverse event: BLEEDING(NON-HEMATOMA)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1524 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1524 at risk

Adverse event: CARDIAC/CORONARY SINUS DISSECTION
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1524 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1524 at risk

Adverse event: ER VISIT AND OBSERVATION ADMISSION
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1524 at risk

Adverse event: EROSION/EXTRUSION
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1524 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1524 at risk

Adverse event: HOSPITALIZATION FOR DECREASED MENTAL STATUS AND FEVER
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1524 at risk

Adverse event: LEAD DISLODGEMENT OR MIGRATION
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 1524 at risk

Adverse event: RA LEAD FRACTURE
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1524 at risk

Adverse event: RV LEAD MALFUNCTION
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1524 at risk

Adverse event: LV LOSS OF CAPTURE
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1524 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 1524 at risk

Adverse event: NEW OR WORSENED ANGINA
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1524 at risk

Adverse event: OTHER Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1524 at risk

Adverse event: OTHER Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1524 at risk

Adverse event: OTHER Gastro
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1524 at risk

Adverse event: OTHER General
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 1524 at risk

Adverse event: OTHER Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1524 at risk

Adverse event: Other Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1524 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1524 at risk

Adverse event: PHRENIC NERVE/DIAPHRAGMATIC STIMULATION
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1524 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1524 at risk

Adverse event: SOB; EDEMA; DIURESIS; MONITORING
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1524 at risk

Adverse event: PULSE GENERATOR MALFUNCTION
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1524 at risk

Adverse event: SHOCK/HYPOTENSION
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1524 at risk

Adverse event: SYNCOPE UNKNOWN ETIOLOGY
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1524 at risk

Adverse event: THROMBO-EMBOLIC EVENT
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1524 at risk

Adverse event: TRIMALLEOLAR FRACTURE RIGHT ANKLE
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1524 at risk

Adverse event: WORSENING CAD
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1524 at risk

Adverse event: ARREST - CARDIOPULMONARY
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1524 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 37 affected / 1524 at risk

Adverse event: BLEEDING(NON-HEMATOMA)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1524 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1524 at risk

Adverse event: CLOSTRIDIUM DIAARHEA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1524 at risk

Adverse event: DECOMPENSATED HF
Serious: no
Organ System: Cardiac disorders
Frequency: 98 affected / 1524 at risk

Adverse event: DIZZINESS, NAUSEA, IRREGULAR HEART BEAT
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1524 at risk

Adverse event: ELEVATED PACING THRESHOLDS
Serious: no
Organ System: Product Issues
Frequency: 14 affected / 1524 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 1524 at risk

Adverse event: Haemothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1524 at risk

Adverse event: HIGH DFT'S
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1524 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 1524 at risk

Adverse event: LEAD DISLODGEMENT OR MIGRATION
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1524 at risk

Adverse event: Lead Noise
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1524 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 1524 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1524 at risk

Adverse event: LOW CARDIAC OUTPUT SYNDROME AND PULMONARY OEDEMA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1524 at risk

Adverse event: LOWER EXTREMITY EDEMA
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1524 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1524 at risk

Adverse event: NEW OR WORSENED ANGINA
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1524 at risk

Adverse event: OTHER Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 1524 at risk

Adverse event: OTHER Gastro
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 1524 at risk

Adverse event: OTHER General
Serious: no
Organ System: General disorders
Frequency: 174 affected / 1524 at risk

Adverse event: OTHER Implant
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1524 at risk

Adverse event: OTHER Infections
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 1524 at risk

Adverse event: Other Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 1524 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 9 affected / 1524 at risk

Adverse event: OVERSENSING RESULTING IN THERAPY
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1524 at risk

Adverse event: PACEMAKER MEDIATED TACHYCARDIA (PMT)
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 1524 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1524 at risk

Adverse event: PHRENIC NERVE/DIAPHRAGMATIC STIMULATION
Serious: no
Organ System: Product Issues
Frequency: 33 affected / 1524 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1524 at risk

Adverse event: SHOCK/HYPOTENSION
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1524 at risk

Adverse event: SYNCOPE UNKNOWN ETIOLOGY
Serious: no
Organ System: General disorders
Frequency: 7 affected / 1524 at risk

Adverse event: THERAPY FOR NON-VENTRICULAR RHYTHM
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 1524 at risk

Adverse event: THROMBO-EMBOLIC EVENT
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1524 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1524 at risk

Adverse event: UPPER RESIRATORY TRACT INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1524 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1524 at risk