Number of events | Number of patients (%) | |
---|---|---|
All device deficiencies | 95 | 37 (68.5%) |
Device deficiency associated to an adverse device effect | 0 | 0 (0.0%) |
Device deficiency that could have led to an adverse event | 0 | 0 (0.0%) |
Device deficiency that led to an action taken with the device | 14 | 11 (20.4%) |