Adverse events—primary outcome
death, illness or injury, birth defect, illness or injury or permanent impairment, congenital abnormality
FETAL DISTRESS, ADVERSE EVENTS, ADVERSE EVENT, DISEASE, EVENT, FETAL DEATH, ADVERSE EVENT, EVENTS
Adverse events, including serious safety events, device-related events and unanticipated events were actively monitored in scheduled and unscheduled visits by the research team. The definitions for adverse events and serious adverse events followed the US Food and Drug Administration guidelines where adverse events were defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device. Adverse events included all hospitalizations and events related to the investigational device or the comparator. This included events related to the procedures involved (any procedure in the clinical investigation plan). For users or other persons, this was restricted to events related to the investigational medical device. Adverse events did not include conditions preexisting to the participant’s enrollment. Preexisting conditions were not reported as adverse events unless the condition had an increased occurrence or intensity. Serious adverse events were defined as adverse events that (a) led to a death; (b) led to a serious deterioration in health that resulted in a life-threatening illness or injury, resulted in a permanent impairment of a body structure or a body function, required in-patient hospitalization or prolongation of existing hospitalization, resulted in medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, or resulted in a substantial disruption in ability to conduct normal life functions; (c) led to fetal distress, fetal death or a congenital abnormality or birth defect; (d) when the event did not fit the above outcomes, but the event may have jeopardized the patient and may have required medical or surgical intervention (treatment) to prevent one of the other outcomes. It did not include in-patient hospitalization for a planned study procedure. Serious adverse events included device deficiencies that might have led to a serious adverse event if (a) suitable action had not been taken or (b) intervention had not been made. A planned hospitalization for preexisting conditions, or a procedure required by the Clinical Investigation Plan, without a serious deterioration in health or to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, was not considered to be a serious adverse event. Adverse events were reviewed by the principal investigator and DMC, and recorded in accordance with Good Clinical Practice and Food and Drug Administration Code of Federal Regulations for Medical Devices guidelines. Source documentation was provided to the study sponsors. Monthly checks of DBS hardware integrity were established by recording electrical impedance values.