Device Survival Probability
SECURA_VR_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | at 116.0 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.9 | 99.9 | 99.8 | 99.8 | 99.8 | 99.7 | 99.7 | 99.6 |
| % |  |
99.7 | 99.5 | 99.3 | 99.1 | 98.7 | 98.2 | 96.4 | 91.6 | 76.2 | 46.5 |
| # | 18211 | 17005 | 16024 | 14931 | 13703 | 12426 | 10262 | 7348 | 2878 | 335 |
- 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 | PUX |
| 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 | 2008-09-15 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 20045 |
| Estimated Active USA Implants | 8159 |
| Normal Battery Depletions | 1284 |
| US Market Release | 2008-09-15 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 20470 |
| Normal Battery Depletions | 1285 |
Malfunctions (USA)
| Therapy Function Not Compromised | 35 |
|---|---|
| Battery | 14 |
| Electrical Component | 10 |
| Possible Early Battery Depletion | 8 |
| Software/Firmware | 2 |
| Other | 1 |
| Therapy Function Compromised | 15 |
| Battery | 7 |
| Electrical Component | 6 |
| Possible Early Battery Depletion | 1 |
| Software/Firmware | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 36 |
|---|---|
| Battery | 14 |
| Electrical Component | 10 |
| Possible Early Battery Depletion | 8 |
| Software/Firmware | 2 |
| Other | 2 |
| Therapy Function Compromised | 15 |
| Battery | 7 |
| Electrical Component | 6 |
| Possible Early Battery Depletion | 1 |
| Software/Firmware | 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
D204VRM_D214VRM_D224VRC_D234VRC_CHRG
Data as of November 8, 2019