D364DRM
Protecta DR M4
Device Survival Probability
| 1 yr | at 23 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.9 | 99.9 | ||||||||
| % |  |
99.8 | 99.7 | ||||||||
| # | 16520 | 271 |
- 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 | ICD |
|---|---|
| NBD Code | DDE-DDDR |
| Max. Delivered Energy | 35J |
| Connector Style | DF4 DR Style |
|---|---|
| Serial Number Prefix | PTC |
| Mass | 73g |
| Volume | 41cc |
| Waveform | Biphasic |
| X-Ray ID | PSI |
DF4 DR Style
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 3.2 | 4.1 | 4.5 | 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; 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 | |
|---|---|
| CE Approval Date | |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 2578 |
| Normal Battery Depletions |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Elective Replacement (ERI)
Charge Time
Data as of March 12, 2013