Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | at 53 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.8 | 99.8 | 99.8 | |||||
| % |  |
99.9 | 99.6 | 99.3 | 99.3 | 99.3 | |||||
| # | 17236 | 13001 | 6685 | 1535 | 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
- There are no advisories for this model.
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | VVE-VVIR |
| Max. Delivered Energy | 35 J |
| Connector Style | Cx Style |
|---|---|
| Serial Number Prefix | PZF |
| 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 | 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
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.
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 10306 |
| Normal Battery Depletions | 4 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 11 |
|---|---|
| Electrical Component | 4 |
| Possible Early Battery Depletion | 1 |
| Software/Firmware | 5 |
| Other | 1 |
| Therapy Function Compromised | 3 |
| Electrical Component | 3 |
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.
Charge Time
Data as of March 12, 2013