Device Survival Probability
D154AWG_D16AWG_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | at 105.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.9 | 99.4 | 97.1 | 96.9 | 96.9 | 96.9 | 96.8 | |
| % |  |
99.6 | 99.3 | 98.9 | 97.4 | 89.1 | 69.8 | 43.5 | 23.6 | 8.3 | |
| # | 63436 | 58180 | 53019 | 48182 | 40953 | 29876 | 16947 | 5787 | 523 |
- 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.
Performance Notes For This Model
- There are no performance notes for this model.
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | DDE-DDDR |
| Max. Delivered Energy | 35 J |
| Connector Style | DR Style |
|---|---|
| Serial Number Prefix | PVV |
| Mass | 68 g |
| Volume | 37 cc |
| Waveform | Biphasic |
| X-Ray ID | PVR |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 4.1 | 4.5 | 4.8 | 5.0 |
| Quarterly | 6.3 | 7.3 | 8.3 | 8.8 |
| Semi-annual | 7.3 | 8.7 | 10.1 | 11.0 |
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
EOS device status is defined as 3 months following an RRT indication assuming the following PSP conditions: 100% DDD pacing at 60 min-1, 2.5 V, 0.4 ms; 500 Ohm pacing load; and 6 full-energy charges. EOS may be indicated before the end of 3 months if the device exceeds these conditions.
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | 2006-03-07 |
| Registered USA Implants | 10 |
| Estimated Active USA Implants | 3 |
| Normal Battery Depletions | 4 |
| US Market Release | |
|---|---|
| CE Approval Date | 2006-03-07 |
| Estimated WW Distribution | 17389 |
| Normal Battery Depletions | 366 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 347 |
|---|---|
| Battery | 1 |
| Electrical Component | 335 |
| Possible Early Battery Depletion | 10 |
| Software/Firmware | 1 |
| Therapy Function Compromised | 6 |
| Electrical Component | 6 |
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.62V on 3 consecutive daily automatic measurments.
Charge Time
D154AWG_D164AWG_CHRG
Data as of February 3, 2017