Serious Event

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Serious Event

Serious Adverse Events (SAEs) are adverse events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability/incapacity, or are congenital anomalies/birth defects. Each serious event is categorized by term, organ system, assessment type, and source vocabulary to provide standardized reporting across clinical trials.

Serious Event path is as follows:

Study -> Results Section -> Adverse Events Module -> Serious Event

Study -> Results Section -> Adverse Events Module -> Serious Event -> Serious Event Stats

Serious Event

Ignite Creation Date: 2025-12-24 @ 12:40 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT00594061
Term: Failed device
Organ System: Ear and labyrinth disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: Nine months post-implantation the child was seen in our clinic for swelling on his right cochlear implant site. The child underwent explantation of the device on his right side and was later re-implanted with a second Nucleus Freedom device.
Study: NCT00594061
Study Brief: Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 1 9 View