Liver Function Test Abnormal |
Other Serious |
3/10/2005 |
17 |
Female |
|
4/10/2006 |
|
Japan |
|
Weight Increased |
Other Serious |
6/28/2005 |
57 |
Female |
77 lb |
7/10/2006 |
Physician |
Japan |
|
Subileus |
Hospitalization |
4/27/2006 |
53 |
Female |
90 lb |
8/23/2006 |
|
Japan |
|
Pulmonary Hypertension |
Death |
12/26/2005 |
82 |
Female |
|
11/30/2006 |
Physician |
Japan |
|
Pulmonary Vein Stenosis |
Hospitalization |
4/2/2006 |
53 |
Female |
100 lb |
11/30/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Subileus |
Hospitalization |
4/27/2006 |
54 |
Female |
90 lb |
12/6/2006 |
|
Japan |
|
Abdominal Pain |
Hospitalization |
6/11/2007 |
|
Female |
138 lb |
9/4/2007 |
|
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Renal Failure Acute |
Hospitalization |
6/11/2007 |
|
Female |
138 lb |
9/5/2007 |
|
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Uterine Leiomyoma |
Hospitalization |
6/11/2007 |
|
Female |
138 lb |
9/11/2007 |
|
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Thrombosis |
Hospitalization |
10/22/2008 |
|
Female |
130 lb |
12/31/2008 |
|
United States |
|
Thrombosis |
Hospitalization |
10/22/2008 |
|
Female |
130 lb |
1/9/2009 |
|
United States |
|
Swelling |
Other Serious |
5/26/2009 |
26 |
Female |
131 lb |
8/7/2009 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Uterine Contractions During Pregnancy |
Required Intervention |
|
28 |
Female |
|
5/12/2010 |
|
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Ventricular Tachycardia |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
10/5/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Ventricular Tachycardia |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
10/18/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Ventricular Tachycardia |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
11/8/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pancreatic Carcinoma Metastatic |
Death |
|
77 |
Female |
|
11/23/2010 |
Physician |
Japan |
|
Gamma-glutamyltransferase Increased |
Hospitalization |
1/11/2010 |
33 |
Female |
|
2/7/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Electrocardiogram Qt Prolonged |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
3/16/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
International Normalised Ratio Increased |
Hospitalization |
3/6/2011 |
|
|
|
4/7/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Alanine Aminotransferase Increased |
Hospitalization |
11/18/2009 |
20 |
Female |
110 lb |
4/11/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pericardial Effusion |
Death |
3/15/2006 |
7 |
Male |
40 lb |
4/12/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Chills |
Death |
3/6/2011 |
|
|
|
4/29/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Renal Failure Acute |
Death |
4/17/2011 |
|
|
|
5/26/2011 |
Physician |
United States |
|
Concomitant Disease Aggravated |
Death |
10/1/2010 |
77 |
Female |
|
6/2/2011 |
Physician |
Japan |
|
Resuscitation |
Hospitalization |
3/6/2011 |
|
|
|
6/2/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Dyspnoea Exertional |
Hospitalization |
4/17/2011 |
|
|
|
6/3/2011 |
Physician |
United States |
|
Anaemia |
Death |
12/25/2007 |
22 |
Female |
106 lb |
6/21/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Implantable Pleural Catheter Insertion |
Life Threatening |
4/17/2011 |
|
|
|
7/14/2011 |
Physician |
United States |
|
Death |
Death |
7/13/2011 |
|
|
|
7/18/2011 |
Pharmacist |
United States |
|
Cellulitis |
Hospitalization |
7/15/2011 |
|
|
|
7/27/2011 |
Physician |
United States |
|
Oedema Peripheral |
Other Serious |
7/1/2011 |
|
|
|
8/19/2011 |
Other Health Professional |
United States |
|
Mental Disorder |
Hospitalization |
6/1/2011 |
|
|
|
9/29/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Flushing |
Other Serious |
9/19/2011 |
|
|
|
9/29/2011 |
Physician |
United States |
|
Chronic Obstructive Pulmonary Disease |
Hospitalization |
8/1/2011 |
|
|
|
10/3/2011 |
Physician |
United States |
|
Dizziness |
Hospitalization |
5/1/2011 |
|
|
|
10/3/2011 |
Physician |
United States |
|
Nausea |
Hospitalization |
9/13/2011 |
|
|
|
10/3/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Damage |
Hospitalization |
9/1/2011 |
|
|
|
10/4/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Oxygen Saturation Decreased |
Other Serious |
9/7/2011 |
|
|
|
10/4/2011 |
Pharmacist |
United States |
|
Dyspnoea |
Hospitalization |
9/13/2011 |
38 |
|
|
10/4/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Diarrhoea |
Other Serious |
9/19/2011 |
|
|
|
10/5/2011 |
Physician |
United States |
|
Chest Pain |
Hospitalization |
9/13/2011 |
|
|
|
10/10/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Medical Device Complication |
Hospitalization |
8/23/2011 |
|
|
|
10/12/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Mental Disorder |
Hospitalization |
6/1/2011 |
|
|
|
10/12/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Chest Pain |
Hospitalization |
9/13/2011 |
38 |
Female |
|
10/13/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Anaemia |
Hospitalization |
7/1/2011 |
|
|
|
10/17/2011 |
Physician |
United States |
|
Clostridium Difficile Colitis |
Hospitalization |
9/13/2011 |
|
|
|
10/20/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Dyspnoea |
Hospitalization |
9/13/2011 |
38 |
Female |
|
10/21/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Ventricular Tachycardia |
Hospitalization |
12/25/2007 |
22 |
Female |
106 lb |
10/26/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hepatic Function Abnormal |
Hospitalization |
2/19/2008 |
40 |
Female |
79 lb |
10/26/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Mental Disorder |
Other Serious |
6/1/2011 |
|
|
|
10/26/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Mental Disorder |
Hospitalization |
6/1/2011 |
|
|
|
10/26/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Syncope |
Hospitalization |
7/1/2011 |
|
|
|
10/28/2011 |
Pharmacist |
United States |
|
Syncope |
Hospitalization |
7/1/2011 |
|
|
|
10/31/2011 |
Physician |
United States |
|
Fall |
Hospitalization |
7/1/2011 |
|
|
|
11/7/2011 |
Other Health Professional |
United States |
|
Sickle Cell Anaemia |
Hospitalization |
10/1/2011 |
|
|
|
11/9/2011 |
Physician |
United States |
|
Lung Transplant |
Hospitalization |
10/1/2011 |
|
|
|
11/10/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Anaemia |
Hospitalization |
5/1/2011 |
|
|
|
11/14/2011 |
Other Health Professional |
United States |
|
Premature Baby |
Other Serious |
|
28 |
Female |
1 lb |
11/15/2011 |
Other Health Professional |
United States |
|
Premature Baby |
Other Serious |
|
28 |
Female |
1 lb |
11/15/2011 |
Other Health Professional |
United States |
|
Gastroenteritis Viral |
Hospitalization |
11/1/2011 |
|
|
|
11/16/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Respiratory Failure |
Other Serious |
11/5/2011 |
|
|
|
11/18/2011 |
Pharmacist |
United States |
|
Aspartate Aminotransferase Increased |
Hospitalization |
10/26/2009 |
20 |
Female |
110 lb |
11/18/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Lung Transplant |
Hospitalization |
1/1/2011 |
|
|
|
11/18/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Lung Transplant |
Hospitalization |
1/1/2011 |
|
|
|
11/18/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hypertension |
Other Serious |
|
28 |
Female |
|
11/18/2011 |
Physician |
United States |
|
Dyspnoea |
Hospitalization |
11/1/2011 |
|
|
|
11/21/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Oesophagogastric Fundoplasty |
Hospitalization |
1/1/2011 |
|
|
|
11/22/2011 |
Physician |
United States |
|
Death |
Death |
10/31/2011 |
|
|
|
11/23/2011 |
Physician |
United States |
|
Dyspnoea |
Other Serious |
9/7/2011 |
|
|
|
11/30/2011 |
Other Health Professional |
United States |
|
Cellulitis Orbital |
Hospitalization |
7/1/2011 |
|
|
|
11/30/2011 |
Physician |
United States |
|
Transfusion |
Hospitalization |
10/8/2005 |
14 |
Male |
79 lb |
12/1/2011 |
Physician |
Japan |
|
Lung Transplant |
Hospitalization |
1/1/2011 |
|
|
|
12/2/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pericarditis |
Hospitalization |
11/1/2011 |
|
|
|
12/7/2011 |
Pharmacist |
United States |
|
Pericarditis |
Hospitalization |
11/1/2011 |
|
|
|
12/9/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Dyspnoea |
Hospitalization |
11/1/2011 |
|
|
|
12/12/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pneumonia |
Hospitalization |
10/30/2011 |
|
|
|
12/13/2011 |
Other Health Professional |
United States |
|
Device Leakage |
Other Serious |
6/1/2011 |
|
|
|
12/13/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Condition Aggravated |
Death |
12/25/2007 |
22 |
Female |
106 lb |
12/14/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pericarditis |
Hospitalization |
11/1/2011 |
|
|
|
12/21/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Systemic Lupus Erythematosus |
Hospitalization |
10/30/2011 |
|
|
|
12/22/2011 |
Physician |
United States |
|
Dyspnoea |
Hospitalization |
12/21/2011 |
|
|
|
12/27/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Anaemia |
Hospitalization |
3/4/2011 |
|
|
|
12/27/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pneumonia |
Other Serious |
12/20/2011 |
|
|
|
1/3/2012 |
Physician |
United States |
|
Device Leakage |
Other Serious |
11/1/2011 |
|
|
|
1/3/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Swelling Face |
Hospitalization |
10/1/2011 |
|
|
|
1/9/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Transfusion |
Hospitalization |
3/4/2011 |
|
|
|
1/9/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Tachycardia |
Death |
12/21/2011 |
|
|
|
1/10/2012 |
Physician |
United States |
|
Pneumonia |
Hospitalization |
12/1/2011 |
|
|
|
1/11/2012 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Death |
Death |
12/30/2011 |
|
|
|
1/12/2012 |
Pharmacist |
United States |
|
Nausea |
Other Serious |
12/6/2011 |
|
|
|
1/12/2012 |
Other Health Professional |
United States |
|
Catheter Site Infection |
Other Serious |
11/1/2011 |
|
|
|
1/12/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Melaena |
Hospitalization |
10/27/2005 |
14 |
Male |
79 lb |
1/18/2012 |
Physician |
Japan |
|
Dyspnoea |
Death |
12/21/2011 |
|
|
|
1/19/2012 |
Physician |
United States |
|
Dyspnoea |
Hospitalization |
12/1/2011 |
|
|
|
1/19/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Atrial Fibrillation |
Hospitalization |
1/10/2012 |
|
|
|
1/19/2012 |
Pharmacist |
United States |
|
Gastrointestinal Disorder |
Hospitalization |
1/11/2012 |
|
|
|
1/20/2012 |
Pharmacist |
United States |
|
Pericardial Effusion |
Hospitalization |
11/1/2011 |
|
|
|
1/25/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hypoxia |
Death |
10/1/2011 |
53 |
Female |
251 lb |
1/27/2012 |
Physician |
United States |
|
Renal Failure Acute |
Hospitalization |
1/23/2012 |
|
|
|
2/1/2012 |
Other Health Professional |
United States |
|
Device Leakage |
Other Serious |
11/1/2011 |
|
|
|
2/1/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Asthenia |
Hospitalization |
10/20/2011 |
|
|
|
2/13/2012 |
Other Health Professional |
United States |
|
Abdominal Pain |
Hospitalization |
12/31/2011 |
|
|
|
2/23/2012 |
Other Health Professional |
United States |
|
Death |
Death |
|
|
Female |
|
2/27/2012 |
Physician |
United States |
|
Dyspnoea |
Life Threatening |
11/3/2011 |
|
|
|
3/1/2012 |
Physician |
United States |
|
Atrial Septal Defect |
Death |
11/5/2011 |
|
|
|
3/6/2012 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pneumonia |
Other Serious |
12/30/2011 |
67 |
Male |
|
3/7/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Lung Transplant |
Hospitalization |
|
|
|
|
3/9/2012 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Nausea |
Other Serious |
12/6/2011 |
|
|
|
3/13/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Arterial Hypertension |
Hospitalization |
1/1/2012 |
|
|
|
3/14/2012 |
Other Health Professional |
United States |
|
Haematemesis |
Other Serious |
2/1/2012 |
|
|
|
3/16/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Cellulitis |
Hospitalization |
1/1/2012 |
|
|
|
3/19/2012 |
Other Health Professional |
United States |
|
Menorrhagia |
Other Serious |
12/6/2011 |
|
|
|
3/20/2012 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Post Procedural Haematoma |
Hospitalization |
12/1/2011 |
|
|
|
3/21/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Malaise |
Hospitalization |
1/1/2012 |
|
|
|
3/22/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Tachycardia |
Death |
12/21/2011 |
|
|
|
3/23/2012 |
Pharmacist |
United States |
|
Diarrhoea |
Hospitalization |
2/1/2012 |
|
|
|
3/26/2012 |
Other Health Professional |
United States |
|
Pulmonary Hypertension |
Hospitalization |
1/1/2012 |
|
|
|
3/26/2012 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Atelectasis |
Hospitalization |
2/27/2012 |
|
|
|
3/27/2012 |
Other Health Professional |
United States |
|
Hallucination |
Hospitalization |
3/1/2012 |
|
|
|
3/28/2012 |
Physician |
United States |
|
Walking Distance Test Abnormal |
Other Serious |
2/1/2012 |
|
|
|
3/29/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Dizziness |
Hospitalization |
1/1/2012 |
|
|
|
3/29/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Issue |
Hospitalization |
11/1/2011 |
|
|
|
4/2/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Vomiting |
Hospitalization |
2/1/2012 |
|
|
|
4/4/2012 |
Pharmacist |
United States |
|
Right Ventricular Failure |
Hospitalization |
|
|
|
|
4/9/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Tremor |
Hospitalization |
1/1/2012 |
|
|
|
4/11/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Toxic Skin Eruption |
Hospitalization |
4/1/2012 |
39 |
Male |
|
4/23/2012 |
Physician |
France |
Primary |
|
Secondary |
|
Concomitant |
|
|
Toxic Skin Eruption |
Hospitalization |
4/1/2012 |
39 |
Male |
|
4/24/2012 |
Physician |
France |
|
Epistaxis |
Hospitalization |
2/8/2011 |
|
|
|
4/30/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Renal Impairment |
Hospitalization |
4/1/2011 |
75 |
Female |
104 lb |
5/4/2012 |
Physician |
Japan |
|
Renal Impairment |
Hospitalization |
3/1/2012 |
|
|
|
5/7/2012 |
Pharmacist |
United States |
|
Nausea |
Life Threatening |
2/1/2012 |
|
|
|
5/8/2012 |
Other Health Professional |
United States |
|
Pain In Jaw |
Other Serious |
12/3/2011 |
|
|
|
5/9/2012 |
Physician |
United States |
|
Weight Decreased |
Hospitalization |
4/20/2012 |
|
|
|
5/15/2012 |
Physician |
United States |
|
Dialysis |
Hospitalization |
4/19/2012 |
|
|
|
5/15/2012 |
Other Health Professional |
United States |
|
Haematocrit Decreased |
Hospitalization |
8/7/2011 |
|
|
|
5/17/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hepatic Function Abnormal |
Hospitalization |
2/19/2008 |
40 |
Female |
79 lb |
5/21/2012 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Right Ventricular Failure |
Hospitalization |
2/8/2011 |
|
|
|
5/21/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pyrexia |
Hospitalization |
12/6/2011 |
|
|
|
5/21/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Dialysis |
Hospitalization |
4/19/2012 |
|
|
|
5/21/2012 |
Other Health Professional |
United States |
|
Pain In Jaw |
Death |
12/1/2011 |
|
|
|
5/22/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Catheter Site Pain |
Hospitalization |
8/1/2011 |
|
|
|
5/22/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Cardiac Failure |
Death |
5/13/2012 |
|
|
|
5/23/2012 |
Physician |
United States |
|
Cardiogenic Shock |
Hospitalization |
3/10/2012 |
|
|
|
5/25/2012 |
Pharmacist |
United States |
|
Lung Disorder |
Death |
2/1/2012 |
|
|
|
5/31/2012 |
Pharmacist |
United States |
|
Death |
Death |
5/13/2012 |
|
|
|
5/31/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Related Infection |
Other Serious |
8/1/2011 |
|
|
|
6/4/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Atrial Flutter |
Other Serious |
4/21/2012 |
|
|
|
6/8/2012 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pleural Effusion |
Hospitalization |
1/1/2011 |
|
|
|
6/8/2012 |
Pharmacist |
United States |
|
Cardio-respiratory Arrest |
Death |
5/12/2012 |
|
|
|
6/13/2012 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|