Device Survival Probability
D144DRG_D154ATG_D154DRG_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | at 102.0 mo | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.8 | 99.6 | 99.4 | 99.4 | 99.3 | 99.3 | 99.3 | ||||||||||||
| % |  |
99.3 | 99.0 | 98.4 | 96.9 | 89.6 | 69.4 | 36.0 | 7.2 | 1.2 | ||||||||||||
| # | 24828 | 22610 | 20237 | 17789 | 14668 | 10501 | 4936 | 856 | 132 |
- 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
Performance Notes For This Model
- There are no performance notes for this model.
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | VVE-DDDR |
| 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 |
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
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | 2008-06-05 |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | 2008-06-05 |
| Estimated WW Distribution | 1860 |
| Normal Battery Depletions | 9 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 2 |
|---|---|
| Possible Early Battery Depletion | 1 |
| Software/Firmware | 1 |
| Therapy Function Compromised | 1 |
| Battery | 1 |
EOL Indication
EOL device status is defined as three months following an ERI indication assuming the following post-ERI conditions: 100% DDD pacing at 60 min-1, 2.5 V, 0.4 ms; 500 Ohm pacing load; and six full-energy charges. EOL may be indicated before the end of three months if the device exceeds these conditions.
Elective Replacement (ERI)
Battery voltage less than or equal to 2.61 V on three consecutive daily automatic measurements.
Charge Time
D144DRG_D154ATG_D154DRG_CHRG
Data as of October 12, 2018