46 Stratos
Table 11: Summary of Observations at 6 months
|
|
| Number of |
| % of | Number of |
| Observations | |
| Category |
|
|
| per patient- | ||||
|
| Patients |
| Patients | Observations |
| |||
|
| ||||||||
|
|
|
|
|
|
|
| year | |
|
|
| Device Related |
|
|
| |||
|
|
|
|
|
|
|
| ||
| infection/ | 1 | 1.1% | 1 | 0.02 |
| |||
| Pericardial |
| |||||||
|
|
|
|
|
|
|
| ||
| Effusion |
|
|
|
|
|
|
| |
| Total | 1 | 1.1% | 1 | 0.02 |
| |||
| Total System | 12 |
| 13.5% | 13 |
| 0.21 |
| |
| Related |
|
|
| |||||
|
|
|
|
|
|
|
| ||
|
|
|
|
| Medical |
|
|
|
|
| Arrhythmias | 2 |
| 2.2% | 2 |
| 0.03 |
| |
| Shortness of |
|
|
|
|
|
|
| |
| breath, | 1 |
| 1.1% | 1 |
| 0.02 |
| |
| palpitations |
|
|
|
|
|
|
| |
| Total | 3 |
| 3.3% | 3 |
| 0.05 |
| |
|
|
|
|
| Miscellaneous |
|
|
|
|
| Malfunction of |
|
|
|
|
|
|
| |
| hemostatic | 1 |
| 1.1% | 1 |
| 0.02 |
| |
| valve |
|
|
|
|
|
|
| |
| Improper |
|
|
|
|
|
|
| |
| Lead | 1 |
| 1.1% | 1 |
| 0.02 |
| |
| preparation |
|
|
|
|
|
|
| |
| Total | 2 |
| 2.2% | 2 |
| 0.04 |
| |
| Overall |
| 17 |
| 19.1% | 18 |
| 0.28 |
|
| Observation |
|
|
|
| ||||
| Totals |
|
|
|
|
|
|
|
|
Number of Patients = 89; Number of
There were a total of 10 patient deaths reported in the OVID study for patients with the Stratos LV device. The clinical investigators determined that no deaths were related to the Stratos LV device system.