Table 1.
Number of patients reporting infections or erosions after each neurostimulator procedure
| Procedure | Total of patients, n | Patients reporting infection1, n | Infection events, n | Patients reporting erosion1, n | Erosion events, n |
|---|---|---|---|---|---|
| 1st | 265 | 6 | 8 | 2 | 2 |
| 2nd | 236 | 8 | 8 | 1 | 1 |
| 3rd | 188 | 8 | 8 | 0 | 0 |
| 4th | 100 | 2 | 2 | 2 | 2 |
| 5th | 37 | 2 | 2 | 0 | 0 |
| 6th | 14 | 2 | 2 | 0 | 0 |
| 7th | 7 | 1 | 1 | 2 | 2 |
| 8th | 2 | 0 | 0 | 0 | 0 |
All serious adverse events related to infection or erosion were identified by the investigator as device related or of uncertain device relation, and were not due to seizure-related injuries. Data as of November 1st, 2015.
1
This column represents the number of unique patients who had an infection or erosion in the time period between the nth and the n + 1st procedure. The sum of patients in this column does not reflect the number of unique patients who ever had an infection/erosion, because any patient having an adverse event in more than one nth procedure bin would be represented multiple times. ©2017 NeuroPace Inc.