W1DR01
Azure XT DR
Device Survival Probability
AZURE_DR_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | at 65.0 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | ||||
| % |  |
100.0 | 100.0 | 99.9 | 99.8 | 99.5 | 99.5 | ||||
| # | 428893 | 295376 | 183341 | 92198 | 16074 | 224 |
- 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
Product Characteristics
| Generator Type | IPG |
|---|---|
| NBD Code | OAE-DDDR |
| Max. Delivered Energy | N/A |
| Connector Style | IS-1 UNI/BI |
|---|---|
| Serial Number Prefix | RNB |
| Mass | 22.5 g |
| Volume | 12.75 cc |
| Waveform | N/A |
| X-Ray ID | RNA |
IS-1 UNI/BI
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 10.3 | 12.3 |
| Nominal 3.5 V (A, RV) | 7.6 | 10.0 |
| High 5.0 V (A, RV) | 5.0 | 7.4 |
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 | 2017-08-16 |
|---|---|
| CE Approval Date | 2017-03-02 |
| Registered USA Implants | 556721 |
| Estimated Active USA Implants | 502775 |
| Normal Battery Depletions | 223 |
| US Market Release | 2017-08-16 |
|---|---|
| CE Approval Date | 2017-03-02 |
| Estimated WW Distribution | 577340 |
| Normal Battery Depletions | 223 |
Malfunctions (USA)
| Therapy Function Not Compromised | 86 |
|---|---|
| Battery | 2 |
| Electrical Component | 45 |
| Possible Early Battery Depletion | 1 |
| Software/Firmware | 19 |
| Other | 19 |
| Therapy Function Compromised | 13 |
| Battery | 2 |
| Electrical Component | 11 |
Malfunctions (WW)
| Therapy Function Not Compromised | 114 |
|---|---|
| Battery | 2 |
| Electrical Component | 55 |
| Possible Early Battery Depletion | 1 |
| Software/Firmware | 21 |
| Other | 35 |
| Therapy Function Compromised | 14 |
| Battery | 2 |
| Electrical Component | 12 |
EOS Indication
From the point that the RRT is set, the pacemaker will operate for approximately six months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.
Data as of May 10, 2023