Device Survival Probability
COBALT_CROME_HF_SURV
| 1 yr | 2 yr | 3 yr | at 45.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 99.9 | 99.9 | ||||||
| % |  |
100.0 | 99.9 | 99.5 | 98.0 | ||||||
| # | 41320 | 22983 | 6831 | 190 |
- 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-Defib |
|---|---|
| NBD Code | DDE-DDDR |
| Max. Delivered Energy | 40 J |
| Serial Number Prefix | RTL |
|---|---|
| Mass | 83 g |
| Volume | 36.3 cc |
| Waveform | Biphasic |
| X-Ray ID | PLS |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 4.5 | 5.0 | 5.4 | 5.5 |
| Quarterly | 6.9 | 8.0 | 8.9 | 9.4 |
| Semi-annual | 8.0 | 9.4 | 10.7 | 11.4 |
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 1.5V; Ventricular Pulse Amplitude 2V; Atrial Impedance 500ohms; Ventricle Impedance 500ohms; Atrial Sensing Rate 70bpm; Ventricle Sensing Rate 70bpm;Atrial Fib percentage of time 0%; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formationHide this content
Distribution Data
| US Market Release | 2020-04-23 |
|---|---|
| CE Approval Date | 2019-12-18 |
| Registered USA Implants | 4646 |
| Estimated Active USA Implants | 4311 |
| Normal Battery Depletions | 4 |
| US Market Release | 2020-04-23 |
|---|---|
| CE Approval Date | 2019-12-18 |
| Estimated WW Distribution | 16958 |
| Normal Battery Depletions | 4 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
EOS Indicator
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 or equal to 2.8 V on 3 consecutive daily automatic measurements.
Data as of April 30, 2024