Device Survival Probability
VIRTUOSO_II_DR_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | at 101.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 99.9 | 99.9 | 99.9 | 99.7 | 99.6 | 99.6 | |
| % |  |
99.8 | 99.6 | 99.3 | 98.7 | 96.2 | 89.4 | 71.2 | 38.9 | 23.2 | |
| # | 19348 | 18171 | 17106 | 15895 | 14170 | 11401 | 7377 | 2281 | 396 |
- 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 | PZS |
| Mass | 68 g |
| Volume | 37 cc |
| Waveform | Biphasic |
| X-Ray ID | PUG |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 3.6 | 4.1 | 4.5 | 4.7 |
| Quarterly | 5.1 | 6.0 | 7.0 | 7.5 |
| Semi-annual | 5.7 | 7.0 | 8.3 | 9.0 |
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
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | 2008-08-20 |
| Registered USA Implants | 1 |
| Estimated Active USA Implants | 0 |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | 2008-08-20 |
| Estimated WW Distribution | 7463 |
| Normal Battery Depletions | 5 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 5 |
|---|---|
| Battery | 1 |
| Electrical Component | 3 |
| Possible Early Battery Depletion | 1 |
| Therapy Function Compromised | 0 |
EOS Indication
The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 3 months assuming the following conditions: 100% DDD pacing at 60 min-1, 2.5 V atrial and RV pacing amplitude; 0.4 ms pulse width; 600 ohm pacing load; and 6 full-energy charges. The EOS may be indicated before the end of 3 months if the device exceeds these conditions.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.
Charge Time
D274DRG_D294DRG_CHRG
Data as of April 11, 2019