D354TRM
Protecta XT CRT-D M4
Device Survival Probability
| 1 yr | at 23 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | ||||||||
| % |  |
99.9 | 99.1 | ||||||||
| # | 16509 | 193 |
- 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.
Advisories For This Model
- There are no advisories for this model.
Product Characteristics
| Generator Type | CRT-Defib |
|---|---|
| NBD Code | |
| Max. Delivered Energy |
| Serial Number Prefix | PSE |
|---|---|
| Mass | |
| Volume | |
| Waveform | |
| X-Ray ID |
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
EOS Indication
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | 2010-07-15 |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | 2010-07-15 |
| Estimated WW Distribution | 6709 |
| Normal Battery Depletions |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 2 |
|---|---|
| Other | 2 |
| Therapy Function Compromised | 0 |
Elective Replacement (ERI)
Charge Time
Data as of March 12, 2013