Device Survival Probability
D154AWG_D16AWG_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 | 15 yr | at 182.0 mo | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 100.0 | 100.0 | 99.9 | 99.4 | 97.1 | 96.9 | 96.8 | 96.8 | 96.7 | 96.6 | 96.5 | 96.4 | 96.4 | 96.4 | 96.4 | 96.4 | ||||||
% | 99.8 | 99.6 | 99.1 | 97.8 | 90.3 | 73.5 | 49.2 | 30.0 | 18.1 | 13.6 | 12.4 | 11.7 | 11.1 | 10.7 | 10.1 | 9.6 | ||||||
# | 63551 | 58491 | 53190 | 47920 | 40414 | 29771 | 17372 | 8914 | 4491 | 2854 | 2363 | 2018 | 1713 | 1408 | 362 | 128 |
- 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 | 35 J |
Connector Style | DR Style |
---|---|
Serial Number Prefix | PVV |
Mass | 68 g |
Volume | 37 cc |
Waveform | Biphasic |
X-Ray ID | PVR |
Estimated Longevity
Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
---|---|---|---|---|
Monthly | 4.1 | 4.5 | 4.8 | 5.0 |
Quarterly | 6.3 | 7.3 | 8.3 | 8.8 |
Semi-annual | 7.3 | 8.7 | 10.1 | 11.0 |
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 formation. Hide this content
Distribution Data
US Market Release | |
---|---|
CE Approval Date | 2006-03-07 |
Registered USA Implants | 3 |
Estimated Active USA Implants | 0 |
Normal Battery Depletions | 2 |
US Market Release | |
---|---|
CE Approval Date | 2006-03-07 |
Estimated WW Distribution | 17786 |
Normal Battery Depletions | 388 |
EOS Indication
EOS device status is defined as 3 months following an RRT indication assuming the following PSP conditions: 100% DDD pacing at 60 min-1, 2.5 V, 0.4 ms; 500 Ohm pacing load; and 6 full-energy charges. EOS may be indicated before the end of 3 months if the device exceeds these conditions.
Data as of December 1, 2023