Stratos
Table 5: Summary of Complications – Stratos LV
| Category | Number | % of | Number of | Complications |
|
| of | per patient- |
| |||
| Patients | Complications |
| |||
|
| Patients | year |
| ||
|
|
| ||||
|
|
|
| |||
|
|
| Device- | Related |
|
|
|
| 2.7% |
|
|
| |
| Infection or | 2 | 3 | 0.05 |
| |
| Pain |
|
|
|
|
|
| Total | 2 | 2.7% | 3 | 0.05 |
|
|
| LV |
|
| ||
| High |
|
|
|
|
|
| Threshold / | 1 | 1.3% | 1 | 0.02 |
|
| No Capture |
|
|
|
|
|
| Diaphragmatic | 1 | 1.3% | 1 | 0.02 |
|
| Stimulation |
| ||||
|
|
|
|
|
| |
| Dislodgement | 2 | 2.7% | 2 | 0.03 |
|
| Total | 4 | 5.3% | 4 | 0.06 |
|
|
| RV Lead Related |
|
| ||
| High |
|
|
|
|
|
| Threshold / | 4 | 5.3% | 4 | 0.06 |
|
| No Capture |
|
|
|
|
|
| Total | 4 | 5.3% | 4 | 0.06 |
|
|
|
| Procedure |
|
| |
| Pneumothorax | 1 | 1.3% | 1 | 0.02 |
|
| User error | 1 | 1.3% | 1 | 0.02 |
|
| Hematoma | 1 | 1.3% | 1 | 0.02 |
|
| Total | 3 | 4.0% | 3 | 0.05 |
|
| Total Lead |
|
|
|
|
|
| and | 11 | 14.7% | 14 | 0.22 |
|
| Procedure |
| ||||
|
|
|
|
|
| |
| Related |
|
|
|
|
|
|
|
| Other | Medical |
|
|
| Worsening | 2 | 2.7% | 2 | 0.03 |
|
| CHF |
| ||||
|
|
|
|
|
| |
|
|
|
|
|
| |
| cardiac | 5 | 6.7% | 5 | 0.08 |
|
| symptoms |
|
|
|
|
|