Device Survival Probability
W1TRXX_SURV
| 1 yr | 2 yr | at 27.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | |||||||
| % |  |
99.9 | 99.9 | 99.9 | |||||||
| # | 2909 | 425 | 122 |
- 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 | CRT-Pacing |
|---|---|
| NBD Code | OAE-DDDR |
| Max. Delivered Energy | N/A |
| Connector Style | CRT-P Style |
|---|---|
| Serial Number Prefix | RNO |
| Mass | 30 g |
| Volume | 19.9 cc |
| Waveform | N/A |
| X-Ray ID | RNP |
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 8.7 | 10.9 |
| Nominal 3.5 V (A, RV) | 6.9 | 8.5 |
| High 5.0 V (A, RV) | 3.9 | 6.0 |
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 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Left Ventricle Pulse Width 0.4 ms; Left Ventricle Pulse Amplitude same as A, RV; Left Ventricle Percent Paced 100 %; Left Ventricle Lead Impedance same as A, RV; EGM Prestorage ON ; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 %Hide this content
Distribution Data
| US Market Release | 2017-05-06 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 3844 |
| Estimated Active USA Implants | 3676 |
| Normal Battery Depletions | 1 |
| US Market Release | 2017-05-06 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 5673 |
| Normal Battery Depletions | 1 |
Malfunctions (USA)
| Therapy Function Not Compromised | 1 |
|---|---|
| Other | 1 |
| Therapy Function Compromised | 1 |
| Electrical Component | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 1 |
|---|---|
| Other | 1 |
| Therapy Function Compromised | 1 |
| Electrical Component | 1 |
EOL Indicator
6 months after RRT
Recommended Replacement (RRT)
180 days after 3 consecutive daily automatic measurements of battery voltage less than or equal to 2.63 V or immediately after 3 consecutive daily automatic measurements of less than or equal to 2.60 V, whichever comes first
Data as of November 8, 2019