Table 3.
Device Related Safety Events and Resolution Reported by the Cross Over Cohort
| Event Description (Number of Patients) | AE Classification | Resolution |
|---|---|---|
| Infection (2) | SADE | System Explant |
| Seroma at the Lead Incision Site (1) | ADE | Apply pressure dressing |
| Infection (2) | ADE | Medication |
| Damage to the IPG or leads causing the system to fail deliver stimulation or causing the system to deliver overstimulation (1) | ADE | System Explant |
| ADE | IPG reposition | |
| Persistent Pain at The IPG Site (1) | ADE | System Explant |
| Lead Migration (2) | ADE | Lead Replacement |
| ADE | Lead Replacement |