Table 3.
Device-Related Complications of the AngelMed Guardian® System in the ALERTS Trial
| Complication | Number of Events/Total Subjects | Percentage (%) |
|---|---|---|
| Cardiac perforation | 2/907 | 0.22 |
| Erosion | 3/907 | 0.33 |
| Infection | 11/907 | 1.21 |
| Lead misplacement | 4/907 | 0.44 |
| Device defect | 2/907 | 0.22 |
| Lead malfunction | 1/907 | 0.11 |
| Signal loss secondary to dislodgement or malfunction of the lead | 2/907 | 0.22 |
| Pain at or near implantation site | 5/907 | 0.55 |
| Visible bump at site of implantation | 1/907 | 0.11 |
| Total | 30/907 | 3.3 (96.7% complication-free rate) |