{"eventGroups":[{"description":"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.\n\nPatients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.\n\nNewBreez: Intralaryngeal prosthesis to protect the airways","id":"EG000","otherNumAffected":1,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"NewBreez"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"device failed to remain in the intended location in the larynx","organSystem":"Product Issues","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Device migration"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"aspiration"}],"timeFrame":"subject 1: 24 hours after receiving the NewBreez implant subject 2: 11 days after receiving the NewBreez implant"}