EV2401
Epsila EV
ALL
Device Survival Probability
EV2401_SURV
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| at 6.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | |||||||||
| # | 81 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 556 |
|---|---|
| Cumulative Months of Follow-Up | 1151 |
| Number of Leads Active in Study | 542 |
1
Qualifying Complications
| Lead Dislodgement | 1 |
|---|
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 0 |
|---|---|
| Failure to Capture | 2 |
| Failure to Sense | 4 |
| Impedance Out of Range | 21 |
| Lead Dislodgement | 12 |
| Oversensing | 39 |
Distribution Data
| US Market Release | 2023-10-20 |
|---|---|
| CE Approval Date | 2023-02-17 |
| Registered USA Implants | 1792 |
| Estimated Active USA Implants | 1731 |
| US Market Release | 2023-10-20 |
|---|---|
| CE Approval Date | 2023-02-17 |
| Estimated WW Distribution | 5004 |
USA Returned Product Analysis
| Conductor Fracture | |
|---|---|
| Insulation Breach | |
| Crimp/Weld/Bond | |
| Other |
WW Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Shaped passive fixation |
| Lead Function | Pacing/Sensing and Defibrillation |
| Lead Placement | Extravascular |
| Lead Tip Location | Anterior mediastinum |
| Pace/Sense Polarity | True Bipolar/Two Coils |
| Serial Number Prefix | EVL |
|---|---|
| Lead Body Diameter | 2.9 mm (8.7 Fr) |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | EV4-LLHH |
| High Voltage Connector | EV4-LLHH |
| Steroid | None |
Data as of May 24, 2025