Study: NCT00289276

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Chest Pain/Angina Pectoris
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Chest Pressure/Tightness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Fatigue/Tiredness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Heart Failure Decompensation
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 47 at risk

Adverse event: Muscle Stimulation - Diaphragm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Acute Cystitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Battery at Elective Replacement Indicator
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Other: COAG - Negative Staphylococcus Bacteremia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Diverticular Disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Fractured Femur
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Indigestion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Infected Fistula (gortex) Right Arm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Marquis Battery Field Action
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 47 at risk

Adverse event: Other: Non-functioning Fistula
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Poorly Functioning Fistula
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Right Carotid Artery Stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Severe Anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Small Bowel Malformation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Stenosis of the Transposed Vessilic Vein
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Other: Uterine Ablation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Oversensing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Premature Battery Failure
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 47 at risk

Adverse event: Renal failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Stroke/CVA
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: General disorders
Frequency: 5 affected / 47 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 47 at risk

Adverse event: Dyspnea/Shortness of Breath
Serious: no
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Fatigue/Tiredness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Heart Failure Decompensation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Other: Fall
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Arm/Hand Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 109 at risk

Adverse event: Back Pain/Discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 109 at risk

Adverse event: Chest Pain/Angina Pectoris
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 109 at risk

Adverse event: Chest Pressure/Tightness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Cold/Flu
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Fatigue/Tiredness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Heart Failure Decompensation
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 109 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 109 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Lead Dislodgment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Muscle Stimulation - Diaphragm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Other: Aberrantly Conducted Rhythm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Amiodarone Toxicity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Arm Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Battery at Elective Replacement Indicator
Serious: yes
Organ System: General disorders
Frequency: 29 affected / 109 at risk

Adverse event: Other: Cardiac Arrest
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Cataracts
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Other: Cholecystitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Clostidium Difficile Colitis Infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Cushing's Syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Effusion of Right Knee Joint
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Enlarged Prostate
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Epicardial Lead Placement in Lateral Wall-Poor Placement
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Fall
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Other: Gastrointestinal Bleed
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Other: Head Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: High INR
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Inappropriate Shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Infected Carbuncle
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Infected Sebaceous Cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Inguinal Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Iron Deficiency Anemia / GI Bleed
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Kidney Stones
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Left Indirect Inguinal Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Leg Cramps
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Marquis Battery Field Action
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 109 at risk

Adverse event: Other: Melena
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Osteoarthritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Pain/Swelling Elbows Bilaterally
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Pancreatitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Peptic Ulcers
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Prostate Enlargement
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Prostate Problems
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Renal Colic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: SVT-Classified as VT with Therapies Delivered
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Sepsis Syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Severe Anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Small Bowel Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Subclavian Artery Stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Urinary Tract Infection
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 109 at risk

Adverse event: Other: Weight Loss, Night Sweats, Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Other: Worsening Osteoarthritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 109 at risk

Adverse event: Rash
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Renal failure
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 109 at risk

Adverse event: Stroke/CVA
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Suspected Generator/ICD Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Bronchitis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 109 at risk

Adverse event: Chest Pain/Angina Pectoris
Serious: no
Organ System: General disorders
Frequency: 8 affected / 109 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: General disorders
Frequency: 14 affected / 109 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 109 at risk

Adverse event: Dyspnea/Shortness of Breath
Serious: no
Organ System: General disorders
Frequency: 8 affected / 109 at risk

Adverse event: Heart Failure Decompensation
Serious: no
Organ System: General disorders
Frequency: 11 affected / 109 at risk

Adverse event: Other: Battery at Elective Replacement Indicator
Serious: no
Organ System: General disorders
Frequency: 7 affected / 109 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 109 at risk