Device Survival Probability
MAXIMO_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 | 13 yr | 14 yr | at 174.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.9 | 99.9 | 99.9 | 99.8 | 99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.6 | 99.6 | 99.6 | 99.6 | ||||||
| % |  |
99.8 | 99.6 | 99.4 | 99.2 | 98.8 | 98.1 | 95.3 | 89.3 | 75.3 | 54.6 | 46.2 | 45.1 | 44.6 | 44.3 | 44.3 | ||||||
| # | 10870 | 10122 | 9420 | 8721 | 8028 | 7335 | 6491 | 5259 | 3411 | 1860 | 1345 | 1077 | 777 | 356 | 138 |
- 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 | DF4 VR Style |
|---|---|
| Serial Number Prefix | PUZ |
| Mass | 73 g |
| Volume | 38 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
Distribution Data
| US Market Release | 2012-05-02 |
|---|---|
| CE Approval Date | 2010-12-17 |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | 2012-05-02 |
|---|---|
| CE Approval Date | 2010-12-17 |
| Estimated WW Distribution | 10038 |
| Normal Battery Depletions | 1 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 2 |
|---|---|
| Battery | 2 |
| Therapy Function Compromised | 1 |
| Battery | 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
D264VRM_D284VRC_D384VRx_D394VRx_CHRG
Data as of November 20, 2024