Serious Event

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: Due to asymmetry in speech perception scores and electrical shorts with device, explantation of the device and reimplantation with a different device was recommended. Device failure report indicated a failed device due to electrode lead malfunction.
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