Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 83 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.8 | 99.7 | 99.4 | 99.4 | 99.3 | |||
| % |  |
99.8 | 99.6 | 99.1 | 97.9 | 90.7 | 70.2 | 34.1 | |||
| # | 26329 | 24093 | 21667 | 19101 | 14919 | 9111 | 787 |
- 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.
Product Characteristics
| Generator Type | ICD |
|---|---|
| NBD Code | DDED, VVED |
| Max. Delivered Energy | 35 J |
| Connector Style | DR Style |
|---|---|
| Serial Number Prefix | PNR |
| Mass | 68 g |
| Volume | 35 cc |
| Waveform | Biphasic |
| X-Ray ID | PNR |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 3.8 | 4.2 | 4.4 | 4.6 |
| Quarterly | 5.5 | 6.1 | 6.8 | 7.0 |
| Semi-annual | 6.1 | 7.0 | 7.9 | 8.3 |
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
EOL Indication
EOL device status is defined as three months following an ERI indication assuming the following post-ERI conditions: 100% DDD pacing at 60 min-1, 2.5 V, 0.4 ms; 500 Ohm pacing load; and six full-energy charges. EOL may be indicated before the end of three months if the device exceeds these conditions.
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 | 1868 |
| Normal Battery Depletions | 3 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 2 |
|---|---|
| Software/Firmware | 1 |
| Other | 1 |
| Therapy Function Compromised | 0 |
Elective Replacement (ERI)
Battery voltage less than or equal to 2.61 V on three consecutive daily automatic measurements.
Charge Time
Data as of March 12, 2013