Table 2.
Serious adverse events
| Subject | Description of SAE | Severity | Device Related | Causality to Study | Outcome |
|---|---|---|---|---|---|
| 1 | Cardiorespiratory arrest | Severe | No | Unrelated | Resolved without sequelae |
| 2 | Pneumoperitoneum | Severe | No | Unrelated | Resolved with sequelaea |
| 2 | Nephrolithiasis | Moderate | No | Unrelated | Resolved without sequelae |
| 3 | Stevens-Johnson Syndrome | Severe | No | Unrelated | Resolved without sequelae |
| 4 | Cardiac arrest | Severe | No | Unrelated | Death |
| 5 | Junctional tachycardia | Severe | No | Unrelated | Resolved with sequelaeb |
| 5 | Vascular graft occlusion | Moderate | No | Unrelated | Resolved without sequelae |
| 5 | Worsening respiratory failure | Severe | No | Unrelated | Death |
| 6 | Cerebral hemorrhage | Severe | No | Unrelated | Not resolvedc |
| 7 | Cardiac arrest | Severe | No | Unrelated | Resolved without sequelae |
| 8 | Pulmonary hemorrhage | Severe | No | Unrelated | Not resolvedc |
| 8 | Adrenal insufficiency | Severe | No | Unrelated | Not resolvedc |
SAE, serious adverse event.
a
Patient underwent subtotal colectomy with placement of an ileostomy.
b
Patient required insertion of a pacemaker.
c
Not resolved events were ongoing at the time of the patient’s death but did not cause the patient’s death.