| Description of Adverse Event | Start Date | Stop Date | Severity Grade | Relationship to Device | Action Taken | Outcome | Expected? | Serious*? | PI Initial and Date |
| Severity Grade | Relationship to Device | Action Taken | Outcome | Expected | Serious |
| 1=Mild 2=Moderate 3=Severe 4=Life-threatening/urgent intervention indicated/ disabling 5=Death related to AE | 1=Not Related 2=Unlikely Related 3=Possibly Related 4=Probably Related 5=Definitely Related | 1 = No change 2 = Device Stopped Temporarily 3 = Device Stopped Permanently 5 = Other | 1 = Recovered/resolved, no sequelea 2 = Recovered/resolved with sequelea 3 = Recovering/resolving 4 = Not recovered/resolved 5 = Unknown 6 = Death/Fatal | 1 = Yes 2 = No | 1 = Yes 2 = No Complete SAE CRF |
*Serious = death, life-threatening, requires hospitalization (initial or prolonged), results in disability or permanent damage, results in congenital abnormality or birth defect, requires intervention to present permanent impairment of damage, or other serious important medical event (based on medical judgment)