Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 74 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.9 | 99.8 | 99.4 | 99.4 | 99.4 | |||
| % |  |
99.9 | 99.8 | 99.6 | 99.2 | 98.1 | 94.2 | 93.6 | |||
| # | 30854 | 28278 | 25609 | 20715 | 10977 | 1687 | 489 |
- 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
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | VVE-VVIR |
| Max. Delivered Energy | 35 J |
| Connector Style | Cx Style |
|---|---|
| Serial Number Prefix | PUP |
| 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 | 4.8 | 5.1 | 5.3 | 5.4 |
| Quarterly | 8.1 | 9.0 | 9.6 | 10.0 |
| Semi-annual | 10.0 | 11.2 | 12.3 | 12.9 |
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
EOS Indication
EOS device status is defined as 3 months following an RRT indication assuming the following PSP conditions: 100% VVI 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 | 5 |
| Estimated Active USA Implants | 5 |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | 2006-03-07 |
| Estimated WW Distribution | 14024 |
| Normal Battery Depletions | 26 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 57 |
|---|---|
| Electrical Component | 42 |
| Possible Early Battery Depletion | 2 |
| Other | 12 |
| Therapy Function Compromised | 10 |
| Electrical Component | 9 |
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.62V on 3 consecutive daily automatic measurments.
Charge Time
Data as of March 12, 2013