Study: NCT00832260

Adverse event: Implant of a Percutaneous transluminal coronary angioplasty (PTCA)
Serious: yes
Organ System: Cardiac disorders
Notes: On November 2009 patient was admitted into the hospital due to chest pain. Treated by Percutaneous transluminal coronary angioplasty (PTCA) On March 2010 two stents in middle descendent artery were implanted. We were aware on the 12 month follow-up.
Frequency: 1 affected / 70 at risk

Adverse event: Hemorrhoids surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hemorrhoids surgery. The patient is discharged from hospital the same day (03/12/2009).
Frequency: 1 affected / 70 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Patient was admitted due to a worsening of bipolar disorder during the hospitalization. The device was implanted on the 7th May 2009. Patient was discharged on the 12th May 2009.
Frequency: 1 affected / 70 at risk

Adverse event: Seizure crisis
Serious: yes
Organ System: Psychiatric disorders
Notes: Patient was hospitalized due to seizure crisis from 21st to 28th October 2009.
Frequency: 1 affected / 70 at risk

Adverse event: Seizure crisis
Serious: yes
Organ System: Psychiatric disorders
Notes: Patient was admitted into the hospital on the 13-Apr-2009 due to seizure crisis, during the hospitalization the device was implanted on the 07-may-2009. Patient discharged on the 29-may-2009.
Frequency: 1 affected / 70 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Exitus - Death due to sudden death 05-jul-2009 (Myocardial infarction)
Frequency: 1 affected / 70 at risk

Adverse event: Pyramidal Syndrome
Serious: yes
Organ System: Nervous system disorders
Notes: Patient was admitted in neurology service due to pyramidal syndrome.
Frequency: 1 affected / 70 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Notes: Patient was admitted in emergency service of another hospital on 16-jul-2009 due to palpitations.
Frequency: 1 affected / 70 at risk

Adverse event: Stent
Serious: yes
Organ System: Cardiac disorders
Notes: Patient is implanted with stent.
Frequency: 1 affected / 70 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization prolonged due to thoracic pain treated with Nitroglycerin.
Frequency: 1 affected / 70 at risk

Adverse event: Transtympanic drain
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Transtympanic drain
Frequency: 1 affected / 70 at risk

Adverse event: Decrease in immunological system
Serious: yes
Organ System: Immune system disorders
Notes: Patient was hospitalized due to a decrease in immunological system.
Frequency: 1 affected / 70 at risk

Adverse event: Tracheotomy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient was admitted in emergency service and he was made a tracheotomy.
Frequency: 1 affected / 70 at risk

Adverse event: Hernia repair
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient was admitted in surgery service to be made a hernioplasty.
Frequency: 1 affected / 70 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Patient suffered a cerebral hemorrhage which caused the patient exitus.
Frequency: 1 affected / 70 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Patient did not present at follow-up so state of event was searched. Unknown cause.
Frequency: 1 affected / 70 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Patient is committed in emergency service on 23-oct-2009 due to acute cholangitis and is discharged on 05-nov-2009. Cholecystectomy performed.
Frequency: 1 affected / 70 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient is admitted at emergency service due to dyspnea.
Frequency: 1 affected / 70 at risk

Adverse event: Prostatectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Patient is admitted at hospital to proceed with prostatectomy.
Frequency: 1 affected / 70 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumothorax tension due to a secondary traumatic punction.
Frequency: 1 affected / 70 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Patient is admitted in emergency service on 10-abr-2010 due to atrial flutter
Frequency: 1 affected / 70 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Macroscopic hematuria due to antiaggregants treatment
Frequency: 1 affected / 70 at risk

Adverse event: Possible strange body in a wound.
Serious: yes
Organ System: Infections and infestations
Notes: Patient was admitted in emergency service due to possible strange body in a wound.
Frequency: 1 affected / 70 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Notes: Patient is admitted in emergency service due to palpitations. Patient was discharged on the same day of admission.
Frequency: 1 affected / 70 at risk