Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | at 99 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.9 | 99.9 | 99.9 | 99.8 | 99.8 | 99.8 | 99.8 | 99.7 | |
| % |  |
99.9 | 99.7 | 99.5 | 99.1 | 97.7 | 91.5 | 83.2 | 70.4 | 53.6 | |
| # | 40772 | 36668 | 32762 | 28752 | 24341 | 18870 | 11716 | 2088 | 346 |
- 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 | VVED |
| Max. Delivered Energy | 35J |
| Connector Style | Cx Style |
|---|---|
| Serial Number Prefix | PRN |
| Mass | 76g |
| Volume | 39cc |
| Waveform | Biphasic |
| X-Ray ID | PRN |
Estimated Longevity
| Charging Frequency | 100% Pacing | 50% Pacing | 15% Pacing | 100% Sensing |
|---|---|---|---|---|
| Monthly | 4.4 | 4.7 | 4.8 | 4.9 |
| Quarterly | 7.0 | 7.5 | 8.0 | 8.3 |
| Semi-annual | 8.2 | 9.0 | 9.7 | 10.0 |
Longevity estimates based on the following device usage. Pacing Mode VVI; Ventricular Lower Pacing Rate 60ppm; Ventricular Pulse Width 0.4ms; Ventricular Pulse Amplitude 3V; Ventricle Impedance 510ohms; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; 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% VVI pacing at 60 ppm, 3 V, 0.4 ms; 500 Ohm pacing load; and six 30 J charges. EOL may be indicated before the end of three months if the device exceeds these conditions.
Distribution Data
| US Market Release | 2003-10-06 |
|---|---|
| CE Approval Date | 2003-10-28 |
| Registered USA Implants | 43594 |
| Estimated Active USA Implants | 18200 |
| Normal Battery Depletions | 2928 |
| US Market Release | 2003-10-06 |
|---|---|
| CE Approval Date | 2003-10-28 |
| Estimated WW Distribution | 73856 |
| Normal Battery Depletions | 3095 |
Malfunctions (USA)
| Therapy Function Not Compromised | 63 |
|---|---|
| Electrical Component | 27 |
| Possible Early Battery Depletion | 23 |
| Other | 13 |
| Therapy Function Compromised | 15 |
| Electrical Component | 12 |
| Electrical Interconnect | 1 |
| Possible Early Battery Depletion | 1 |
| Other | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 126 |
|---|---|
| Battery | 1 |
| Electrical Component | 67 |
| Possible Early Battery Depletion | 32 |
| Software/Firmware | 3 |
| Other | 23 |
| Therapy Function Compromised | 22 |
| Electrical Component | 19 |
| Electrical Interconnect | 1 |
| Possible Early Battery Depletion | 1 |
| Other | 1 |
Elective Replacement (ERI)
Battery voltage less than or equal to 2.62v or charge time greater than 16 seconds.
Charge Time
Data as of March 12, 2013