E1DR06
EnPulse DR
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | at 106 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | |
| % |  |
100.0 | 100.0 | 99.8 | 99.0 | 98.1 | 96.6 | 86.9 | 60.1 | 24.4 | |
| # | 6221 | 5769 | 5326 | 4851 | 4407 | 3950 | 3177 | 1788 | 287 |
- Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
- Excluding Normal Battery Depletion – This is the malfunction free survival curve.
Advisories For This Model
- There are no advisories for this model.
Product Characteristics
| Generator Type | IPG |
|---|---|
| NBD Code | DDDR |
| Max. Delivered Energy |
| Connector Style | 5/6mm UNI |
|---|---|
| Serial Number Prefix | PRE |
| Mass | 28.5 |
| Volume | 14.2 |
| Waveform | |
| X-Ray ID | PRE |
5/6mm UNI
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 7.5 | 8.5 |
| Nominal 3.5 V (A, RV) | 6.2 | 7.6 |
| High 5.0 V (A, RV) | 4.4 | 5.9 |
Longevity estimates based on the following device usage. Pace/Sense Mode DDD ; Atrial Pulse Width 0.4 ms; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Atrial Fib Percent of Time 0 %Hide this content
EOL Indication
3 months after ERI.
Distribution Data
| US Market Release | 2003-12-18 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | 2003-12-18 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | |
| Normal Battery Depletions |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Elective Replacement (ERI)
Telemetry indiction. Rate and mode change to 65 ppm and VVI (VOO/65 with magnet).
Data as of March 12, 2013