Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 74 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.9 | 99.5 | 98.6 | 98.5 | 98.5 | |||
| % |  |
99.9 | 99.7 | 99.4 | 98.0 | 93.0 | 74.7 | 68.0 | |||
| # | 67691 | 62343 | 56556 | 45139 | 23727 | 2918 | 589 |
- 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
Performance Notes For This Model
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | DDED |
| Max. Delivered Energy | 35J |
| Connector Style | DR Style |
|---|---|
| Serial Number Prefix | PUL |
| Mass | 68g |
| Volume | 37cc |
| Waveform | Biphasic |
| X-Ray ID | PVR |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 4.1 | 4.5 | 4.8 | 5.0 |
| Quarterly | 6.3 | 7.3 | 8.3 | 8.8 |
| Semi-annual | 7.3 | 8.7 | 10.1 | 11.0 |
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
EOS Indication
EOS device status is defined as 3 months following an RRT indication assuming the following PSP conditions: 100% DDD pacing at 60 bpm, 2.5 V, 0.4 ms; 500 Ohm pacing load; and 6 full-energy charges. EOS may be indicated before the end of 3 months if the device exceeds these conditions.
Distribution Data
| US Market Release | 2006-05-12 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 72662 |
| Estimated Active USA Implants | 44344 |
| Normal Battery Depletions | 2496 |
| US Market Release | 2006-05-12 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 73416 |
| Normal Battery Depletions | 2499 |
Malfunctions (USA)
| Therapy Function Not Compromised | 614 |
|---|---|
| Electrical Component | 465 |
| Electrical Interconnect | 2 |
| Possible Early Battery Depletion | 117 |
| Software/Firmware | 1 |
| Other | 29 |
| Therapy Function Compromised | 26 |
| Electrical Component | 24 |
| Possible Early Battery Depletion | 1 |
| Other | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 622 |
|---|---|
| Electrical Component | 470 |
| Electrical Interconnect | 2 |
| Possible Early Battery Depletion | 117 |
| Software/Firmware | 2 |
| Other | 31 |
| Therapy Function Compromised | 26 |
| Electrical Component | 24 |
| Possible Early Battery Depletion | 1 |
| Other | 1 |
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.62v.
Charge Time
Data as of March 12, 2013