Table 1.
Rates of Reported Events From Both DRG and SCS Systems.
| Event description | SCS incidence rate | DRG incidence rate |
|---|---|---|
| Allergic reaction | 0.09% | 0.18% |
| Cardiovascular changes | 0.04% | 0 |
| CSF leaks | 0.30% | 0.54% |
| Device related pain | 0.30% | 0.54% |
| Diminished or loss of motor or musculoskeletal symptom control | 0.09% | 0 |
| Gastroesophageal or gastrointestinal changes | 0 | 0.18% |
| Headache | 0.04% | 0 |
| Hematoma | 0.17% | 0 |
| Infection | 1.12% | 1.08% |
| Neurological deficit/dysfunction (NDD) | 0.13% | 0 |
| Persistent pain at the implant site | 0.56% | 0.18% |
| Pocket heating | 0.04% | 0 |
| Post Op pain | 0 | 0 |
| Pulmonary changes | 0.04% | 0 |
| Reduced surgical would healing | 0.17% | 0.18% |
| Seizure | 0.04% | 0 |
| Skin erosion | 0.04% | 0.36% |
| Total incidence rate | 3.09% | 3.24% |
N = >500 systems for DRG and n = >2000 systems for SCS.