DVMB1D4
Evera MRI XT
Device Survival Probability
EVERA_VR_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | at 124.0 mo | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 99.9 | 99.8 | 99.8 | 99.6 | 99.6 | 99.5 | 99.4 | 99.3 | 99.3 | ||||||||||
| % |  |
100.0 | 99.9 | 99.7 | 99.6 | 99.4 | 99.1 | 98.9 | 98.7 | 98.3 | 97.7 | 97.5 | ||||||||||
| # | 52431 | 48794 | 45402 | 42247 | 39173 | 36002 | 33070 | 26184 | 13541 | 3207 | 436 |
- 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.
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | VVE-VVIR |
| Max. Delivered Energy | 36 J |
| Connector Style | DF4 VR Style |
|---|---|
| Serial Number Prefix | PKZ |
| Mass | 77 g |
| Volume | 33 cc |
| Waveform | Biphasic |
| X-Ray ID | PFZ |
DF4 VR Style
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 4.9 | 5.3 | 5.7 | 5.8 |
| Quarterly | 7.8 | 8.8 | 9.7 | 10.1 |
| Semi-annual | 8.5 | 9.7 | 10.7 | 11.3 |
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 formationHide this content
Distribution Data
| US Market Release | 2015-09-11 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 20550 |
| Estimated Active USA Implants | 13817 |
| Normal Battery Depletions | 18 |
| US Market Release | 2015-09-11 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 24156 |
| Normal Battery Depletions | 18 |
Malfunctions (USA)
| Therapy Function Not Compromised | 16 |
|---|---|
| Battery | 12 |
| Electrical Component | 3 |
| Other | 1 |
| Therapy Function Compromised | 18 |
| Battery | 14 |
| Device-Related Current Pathway | 4 |
Malfunctions (WW)
| Therapy Function Not Compromised | 16 |
|---|---|
| Battery | 12 |
| Electrical Component | 3 |
| Other | 1 |
| Therapy Function Compromised | 18 |
| Battery | 14 |
| Device-Related Current Pathway | 4 |
EOS Indication
From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than 2.73V on 3 consecutive daily automatic measurments.
Charge Time
BLACKWELL_VR_CHRG
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Data as of April 30, 2024