Device Survival Probability
SECURA_DR_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 | 99.9 | 99.9 | 99.8 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.4 | 99.4 | 99.4 | 99.4 | ||||||||
| % |  |
99.7 | 99.4 | 99.1 | 98.0 | 95.3 | 87.9 | 70.0 | 38.3 | 23.2 | 21.1 | 20.3 | 19.8 | 19.3 | ||||||||
| # | 44539 | 41184 | 38104 | 34984 | 31060 | 25090 | 16328 | 6713 | 3241 | 2529 | 1874 | 1042 | 104 |
- 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 | ICD |
|---|---|
| NBD Code | DDE-DDDR |
| Max. Delivered Energy | 35 J |
| Connector Style | DR Style |
|---|---|
| Serial Number Prefix | PUG |
| Mass | 68g |
| Volume | 37cc |
| Waveform | Biphasic |
| X-Ray ID | PUG |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 3.6 | 4.1 | 4.5 | 4.7 |
| Quarterly | 5.1 | 6.0 | 7.0 | 7.5 |
| Semi-annual | 5.7 | 7.0 | 8.3 | 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; 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 | 49639 |
| Estimated Active USA Implants | 5403 |
| Normal Battery Depletions | 10310 |
| US Market Release | 2008-09-15 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 50530 |
| Normal Battery Depletions | 10318 |
Malfunctions (USA)
| Therapy Function Not Compromised | 115 |
|---|---|
| Battery | 14 |
| Electrical Component | 38 |
| Possible Early Battery Depletion | 50 |
| Software/Firmware | 9 |
| Other | 4 |
| Therapy Function Compromised | 37 |
| Battery | 21 |
| Electrical Component | 13 |
| Possible Early Battery Depletion | 1 |
| Software/Firmware | 1 |
| Other | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 116 |
|---|---|
| Battery | 14 |
| Electrical Component | 39 |
| Possible Early Battery Depletion | 50 |
| Software/Firmware | 9 |
| Other | 4 |
| Therapy Function Compromised | 37 |
| Battery | 21 |
| Electrical Component | 13 |
| Possible Early Battery Depletion | 1 |
| Software/Firmware | 1 |
| Other | 1 |
EOS Indication
The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 3 months assuming the following conditions: 100% DDD pacing at 60 min-1, 2.5 V atrial and RV pacing amplitude; 0.4 ms pulse width; 600 Ω pacing load; and 6 full-energy charges. The EOS may be indicated before the end of 3 months if the device exceeds these conditions.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.
Charge Time
D204DRM_D214DRM_D224DRG_D234DRG_CHRG
Data as of May 10, 2023