DDMB1D4
Evera MRI XT
Device Survival Probability
EVERA_DR_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 127.0 mo | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 100.0 | 100.0 | 100.0 | 99.9 | 99.9 | 99.8 | 99.8 | 99.7 | 99.7 | 99.7 | 99.7 | |||||||||||
% | 99.9 | 99.9 | 99.8 | 99.7 | 99.5 | 99.1 | 97.8 | 94.8 | 89.5 | 76.7 | 52.0 | |||||||||||
# | 218225 | 198372 | 176480 | 156414 | 129273 | 100416 | 72513 | 46264 | 24723 | 8359 | 916 |
- 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 | DDE-DDDR |
Max. Delivered Energy | 36 J |
Connector Style | DF4 DR Style |
---|---|
Serial Number Prefix | PFZ |
Mass | 78 g |
Volume | 34 cc |
Waveform | Biphasic |
X-Ray ID | PFZ |
DF4 DR Style
Estimated Longevity
Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
---|---|---|---|---|
Monthly | 4.1 | 4.6 | 5.1 | 5.4 |
Quarterly | 5.9 | 7.0 | 8.3 | 9.0 |
Semi-annual | 6.2 | 7.6 | 9.0 | 9.8 |
Longevity estimates based on the following device usage. Pacing Mode DDD; Atrial Lower Pacing Rate 60ppm; Ventricular Lower Pacing Rate 60ppm; Atrial Pulse Width 0.4ms; Ventricular Pulse Width 0.4ms; Atrial Pulse Amplitude 3V; Ventricular Pulse Amplitude 3V; Atrial Impedance 510ohms; Ventricle Impedance 510ohms; Atrial Sensing Rate 70bpm; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Optivol ON; Atrial Fib percentage of time 0%; 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 | 107052 |
Estimated Active USA Implants | 84706 |
Normal Battery Depletions | 960 |
US Market Release | 2015-09-11 |
---|---|
CE Approval Date | |
Estimated WW Distribution | 139340 |
Normal Battery Depletions | 960 |
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.
Data as of November 20, 2024