Adverse events and system complications that were reported for the 19 patients included in the analysis
| Reported (n) | Resolved (n) | Ongoing (n) | |
|---|---|---|---|
| Adverse events related to stimulation | |||
| Paraesthesiae | 6 | 3 | 3 |
| Dysarthria | 4 | 1 | 3 |
| Gait disorders | 3 | 3 | – |
| Dystonia | 1 | – | 1 |
| Local adverse symptoms | |||
| Headaches | 2 | – | 2 |
| Head and chest pain | 1 | 1 | – |
| Pain at pocket site | 2 | 2 | – |
| Pain at connector site | 1 | 1 | – |
| Local pain over pulse generator | 1 | 1 | – |
| Postoperative adverse events related to surgery | |||
| Infection | 2 | 2 | – |
| Erosion | 2 | 2 | – |
| Skin irritation | 2 | 2 | – |
| Subcutaneous haematoma | 1 | 1 | – |
| Paresis | 1 | 1 | – |
| Lead repositioning owing to unsatisfactory effect | 1 | 1 | |
| Other adverse events | |||
| Fracture left wrist | 1 | 1 | – |
| Fracture right clavicle | 1 | 1 | – |
| Subtotal | 32 | 23 | 9 |
| Hardware related adverse events | |||
| End of battery life | 5 | 5 | |
| Loss of effect for other reasons | 2 | 2 | |
| Intermittent stimulation | 1 | 1 | |
| Subtotal | 8 | 8 | – |
| Total | 40 | 31 | 9 |