D154DRG
EnTrust
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 83 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.8 | 99.7 | 99.4 | 99.4 | 99.3 | |||
| % |  |
99.8 | 99.6 | 99.1 | 97.9 | 90.7 | 70.2 | 34.1 | |||
| # | 26329 | 24093 | 21667 | 19101 | 14919 | 9111 | 787 |
- 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.
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | DDED, VVED |
| Max. Delivered Energy | 35 J |
| Connector Style | DR Style |
|---|---|
| Serial Number Prefix | PNR |
| Mass | 68 g |
| Volume | 35 cc |
| Waveform | Biphasic |
| X-Ray ID | PNR |
DR Style
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 3.8 | 4.2 | 4.4 | 4.6 |
| Quarterly | 5.5 | 6.1 | 6.8 | 7.0 |
| Semi-annual | 6.1 | 7.0 | 7.9 | 8.3 |
Longevity estimates based on the following device usage. Pacing Mode DDD; Atrial Lower Pacing Rate 60ppm; Ventricular Lower Pacing Rate 60ppm; Atrial Pulse Width 0.4ms; Ventricular Pulse Width 0.4ms; Atrial Pulse Amplitude 3V; Ventricular Pulse Amplitude 3V; Atrial Impedance 510ohms; Ventricle Impedance 510ohms; Atrial Sensing Rate 70bpm; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Optivol ON; Atrial Fib percentage of time 0%; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation. Hide this content
EOS Indication
3 months after RRT or > 16-second charge time
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | 2005-02-04 |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | 2005-02-04 |
| Estimated WW Distribution | |
| Normal Battery Depletions |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Recommended Replacement (RRT)
Battery Voltage ≤ 2.61 V
Charge Time
Data as of March 12, 2013