Device Survival Probability
CONSULTA_CRT_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 | at 150.0 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.7 | 99.3 | 98.8 | 98.7 | 98.5 | 98.4 | 98.4 | 98.4 | 98.4 | 98.3 | 98.3 | 98.3 | ||||||||
| % |  |
99.7 | 98.4 | 93.3 | 81.3 | 58.9 | 29.8 | 20.1 | 18.1 | 17.4 | 16.8 | 16.4 | 16.2 | 15.6 | ||||||||
| # | 56120 | 50207 | 42858 | 33041 | 19342 | 7426 | 4006 | 3258 | 2899 | 2497 | 1828 | 973 | 181 |
- 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
- There are no communications for this model.
Product Characteristics
| Generator Type | CRT-Defib |
|---|---|
| NBD Code | DDE-DDDR |
| Max. Delivered Energy | 35 J |
| Connector Style | CRT-D Style |
|---|---|
| Serial Number Prefix | PUD |
| Mass | 68 g |
| Volume | 38 cc |
| Waveform | Biphasic |
| X-Ray ID | PUG |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 3.2 | 3.8 | 4.4 | 4.7 |
| Quarterly | 4.4 | 5.5 | 6.8 | 7.5 |
| Semi-annual | 4.8 | 6.2 | 7.9 | 9.0 |
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; Integrated bi-ventricular pacing RV+LV; Left Ventricle Impedance 510ohms; Left Ventricular Pulse Width 0.4ms; Left Ventricular Pulse Amplitude 3V; 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 | 2008-09-15 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 65129 |
| Estimated Active USA Implants | 5056 |
| Normal Battery Depletions | 18950 |
| US Market Release | 2008-09-15 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 66577 |
| Normal Battery Depletions | 18977 |
Malfunctions (USA)
| Therapy Function Not Compromised | 573 |
|---|---|
| Battery | 2 |
| Electrical Component | 67 |
| Electrical Interconnect | 1 |
| Possible Early Battery Depletion | 496 |
| Software/Firmware | 6 |
| Other | 1 |
| Therapy Function Compromised | 31 |
| Battery | 5 |
| Electrical Component | 26 |
Malfunctions (WW)
| Therapy Function Not Compromised | 576 |
|---|---|
| Battery | 2 |
| Electrical Component | 69 |
| Electrical Interconnect | 1 |
| Possible Early Battery Depletion | 497 |
| Software/Firmware | 6 |
| Other | 1 |
| Therapy Function Compromised | 31 |
| Battery | 5 |
| Electrical Component | 26 |
EOS Indication
From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than 2.63 V or Charge Time greater than 16 seconds.
Charge Time
D204TRM_D214TRM_D224TRK_D234TRK_CHRG
Data as of May 10, 2023