Study: NCT00010374

Adverse event: Death while device was not in use
Serious: yes
Organ System: General disorders
Notes: Two of the deaths occurred while the patient was being mechanically ventilated and not paced. In one case the patient was found lifeless during the night; in another case the patient died of cardiac arrhythmia and subsequent cardiac failure.
Frequency: 2 affected / 53 at risk

Adverse event: Death while device was in use
Serious: yes
Organ System: General disorders
Notes: One patient was observed to lose consciousness while the device was functioning. A second patient died of septic shock due to urosepsis and was using the device prior to a hypotensive arrest. No device malfunction was observed.
Frequency: 2 affected / 53 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 53 at risk

Adverse event: Acute Polynephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Elevated Temperature
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Blood from and around treacheostomy tube
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 53 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 53 at risk

Adverse event: Pain/discomfort with stimulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: without evidence of respiratory distress, hypoxemia or aspiration
Frequency: 3 affected / 53 at risk

Adverse event: Increased secretions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Low oxygen saturation/tidal volume
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Capnothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 53 at risk

Adverse event: Broken External Wire
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 53 at risk

Adverse event: External Equipment Failure
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 53 at risk

Adverse event: Elevated Temperature
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Broken Anode
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 53 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes Cold/Nasal Congestion
Frequency: 5 affected / 53 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pain/Discomfort no device use
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk