Device Survival Probability
VIRTUOSO_II_VR_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | at 152.0 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 99.9 | 99.9 | 99.9 | 99.8 | 99.7 | 99.7 | 99.7 | 99.5 | 99.5 | 99.5 | 99.5 | ||||||||
| % |  |
99.7 | 99.7 | 99.4 | 99.2 | 98.8 | 98.3 | 96.8 | 92.1 | 80.9 | 56.6 | 47.3 | 46.0 | 45.1 | ||||||||
| # | 7679 | 7161 | 6654 | 6137 | 5664 | 5131 | 4570 | 3748 | 2498 | 1292 | 881 | 559 | 149 |
- 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.
Customer Communications For This Model
- There are no communications for this model.
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | VVE-VVIR |
| Max. Delivered Energy | 35 J |
| Connector Style | Cx Style |
|---|---|
| Serial Number Prefix | PZR |
| Mass | 68g |
| Volume | 37cc |
| Waveform | Biphasic |
| X-Ray ID | PUG |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 4.3 | 4.7 | 4.9 | 5.0 |
| Quarterly | 6.7 | 7.5 | 8.1 | 8.4 |
| Semi-annual | 7.8 | 8.9 | 9.8 | 10.3 |
Longevity estimates based on the following device usage. Pacing Mode VVI; Ventricular Lower Pacing Rate 60ppm; Ventricular Pulse Width 0.4ms; Ventricular Pulse Amplitude 3V; Ventricle Impedance 510ohms; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Optivol ON; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation. Hide this content
Distribution Data
| US Market Release | 2009-08-15 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 9131 |
| Estimated Active USA Implants | 1363 |
| Normal Battery Depletions | 884 |
| US Market Release | 2009-08-15 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 9285 |
| Normal Battery Depletions | 884 |
Malfunctions (USA)
| Therapy Function Not Compromised | 13 |
|---|---|
| Battery | 6 |
| Electrical Component | 4 |
| Possible Early Battery Depletion | 2 |
| Software/Firmware | 1 |
| Therapy Function Compromised | 8 |
| Battery | 7 |
| Electrical Component | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 14 |
|---|---|
| Battery | 6 |
| Electrical Component | 5 |
| Possible Early Battery Depletion | 2 |
| Software/Firmware | 1 |
| Therapy Function Compromised | 8 |
| Battery | 7 |
| Electrical Component | 1 |
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% VVI pacing at 60 min-1, 2.5 V RV pacing amplitude; 0.4 ms pulse width; 600 Ω 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
D274VRC_D294VRC_CHRG
Data as of May 10, 2023