REDR01
Relia DR
Device Survival Probability
ADDR01_ADDR03_ADDR06_ADD01_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 | 11 yr | 12 yr | 13 yr | 14 yr | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | ||||||||
% | 99.9 | 99.9 | 99.8 | 99.6 | 99.3 | 98.8 | 97.9 | 94.9 | 87.6 | 74.5 | 60.7 | 45.4 | 31.7 | 15.4 | ||||||||
# | 393167 | 365261 | 338800 | 313064 | 289162 | 264932 | 240345 | 209077 | 167005 | 120676 | 76751 | 40118 | 14946 | 465 |
- 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 | IPG |
---|---|
NBD Code | DDDR |
Max. Delivered Energy | N/A |
Connector Style | IS-1 UNI/BI |
---|---|
Serial Number Prefix | NWT |
Mass | 27.1 g |
Volume | 12.1 cc |
Waveform | N/A |
X-Ray ID | PWB |
IS-1 UNI/BI
Estimated Longevity
Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
---|---|---|
Low 2.5 V (A, RV) | 9.1 | 10.3 |
Nominal 3.5 V (A, RV) | 7.2 | 9.0 |
High 5.0 V (A, RV) | 5.1 | 7.0 |
Longevity estimates based on the following device usage. Pace/Sense Mode DDD ; Atrial Pulse Width 0.4 ms; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; EGM Prestorage ON ; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 %Hide this content
Distribution Data
US Market Release | |
---|---|
CE Approval Date | 2008-05-07 |
Registered USA Implants | 11 |
Estimated Active USA Implants | 3 |
Normal Battery Depletions | 2 |
US Market Release | |
---|---|
CE Approval Date | 2008-05-07 |
Estimated WW Distribution | 224616 |
Normal Battery Depletions | 67 |
EOS Indication
The prolonged service period is 3 months after RRT/ERI and assumes 100% pacing at VVI/65 and the listed parameter values. Reprogramming of parameters may shorten the duration of the prolonged service period.
Data as of November 20, 2024