SVDD303
Sigma 300 VDD
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | at 124 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 99.8 | 99.2 | 99.2 | 98.8 | |
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 99.7 | 99.1 | 96.6 | 93.2 | 85.8 | 63.4 | |
| # | 891 | 820 | 770 | 717 | 662 | 610 | 541 | 463 | 317 | 137 | 106 |
- 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
Product Characteristics
| Generator Type | IPG |
|---|---|
| NBD Code | VDD |
| Max. Delivered Energy | N/A |
| Connector Style | 3.2mm Long Pin |
|---|---|
| Serial Number Prefix | PJD |
| Mass | 22.8 g |
| Volume | 11.6 cc |
| Waveform | N/A |
| X-Ray ID | PJD |
3.2mm Long Pin
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 8.9 | 9.7 |
| Nominal 3.5 V (A, RV) | 7.3 | 8.6 |
| High 5.0 V (A, RV) | 5.8 | 7.4 |
Longevity estimates based on the following device usage. Pace/Sense Mode VVI ; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; Activity ONHide this content
EOL Indication
3 months after ERI.
Distribution Data
| US Market Release | 1999-09-15 |
|---|---|
| CE Approval Date | 1998-12-17 |
| Registered USA Implants | 649 |
| Estimated Active USA Implants | 81 |
| Normal Battery Depletions | 67 |
| US Market Release | 1999-09-15 |
|---|---|
| CE Approval Date | 1998-12-17 |
| Estimated WW Distribution | 20995 |
| Normal Battery Depletions | 481 |
Malfunctions (USA)
| Therapy Function Not Compromised | 0 |
|---|---|
| Therapy Function Compromised | 1 |
| Electrical Interconnect | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 10 |
|---|---|
| Electrical Interconnect | 8 |
| Possible Early Battery Depletion | 1 |
| Other | 1 |
| Therapy Function Compromised | 92 |
| Electrical Interconnect | 92 |
Elective Replacement (ERI)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).
Data as of March 12, 2013