Table 7. Adverse events related to device or procedure rated as severe.
| Event | n (%)a | Pre-existing conditionb |
|---|---|---|
| Related to device Neuropathy due to malpositioned implant |
1 (0.6%) 1 (0.6%) |
NA |
| Related to procedure Neuropathy due to malpositioned implantc Postoperative nausea/vomiting Postoperative pain requiring hospitalization Wound infection |
4 (2.3%) 1 (0.6%) 1 (0.6%) 1 (0.6%) 1 (0.6%) |
NA NA Chronic pain disorder, opiate dependence NA |
Abbreviation: NA, not applicable.
Note: One additional site was terminated from the study due to poor study compliance. All data from this site was excluded in this report and the site reported no serious adverse events.
a
Number of events and rate.
b
Pre-existing condition, if present; NA if no known condition.
c
Event also rated as device-related.