Device Survival Probability
W4TRXX_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | at 70.0 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 99.9 | 99.9 | ||||
| % |  |
100.0 | 100.0 | 99.8 | 99.2 | 98.2 | 97.6 | ||||
| # | 46004 | 32455 | 20708 | 11803 | 4412 | 200 |
- 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 | CRT-Pacing |
|---|---|
| NBD Code | OAE-DDDR |
| Max. Delivered Energy | N/A |
| Serial Number Prefix | RNP |
|---|---|
| Mass | 30 g |
| Volume | 19.5 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 | 47669 |
| Estimated Active USA Implants | 40917 |
| Normal Battery Depletions | 80 |
| US Market Release | 2017-05-06 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 51955 |
| Normal Battery Depletions | 80 |
Malfunctions (USA)
| Therapy Function Not Compromised | 9 |
|---|---|
| Electrical Component | 7 |
| Possible Early Battery Depletion | 1 |
| Other | 1 |
| Therapy Function Compromised | 1 |
| Electrical Component | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 9 |
|---|---|
| Electrical Component | 7 |
| Possible Early Battery Depletion | 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 May 10, 2023