SSR306
Sigma 300 SR
Device Survival Probability
| 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 146 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 99.9 | 99.8 | 99.7 | 99.7 | 99.7 | 99.6 | 99.6 | 99.6 | ||||||||
| % |  |
99.9 | 99.9 | 99.7 | 99.5 | 99.2 | 98.6 | 97.5 | 95.6 | 92.1 | 85.8 | 76.0 | 62.7 | 58.2 | ||||||||
| # | 47111 | 39971 | 34129 | 29348 | 25262 | 21010 | 16840 | 13027 | 9324 | 5638 | 2810 | 576 | 252 |
- 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 | SSIR |
| Max. Delivered Energy | N/A |
| Connector Style | 5/6mm UNI |
|---|---|
| Serial Number Prefix | PJH |
| Mass | 21.6 g |
| Volume | 10.8 cc |
| Waveform | N/A |
| X-Ray ID | PJH |
5/6mm UNI
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 10.1 | 11.1 |
| Nominal 3.5 V (A, RV) | 8.2 | 9.8 |
| High 5.0 V (A, RV) | 6.4 | 8.4 |
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 ppmHide this content
EOL Indication
3 months after ERI.
Distribution Data
| US Market Release | 1999-09-07 |
|---|---|
| CE Approval Date | 1998-12-17 |
| Registered USA Implants | 2211 |
| Estimated Active USA Implants | 345 |
| Normal Battery Depletions | 95 |
| US Market Release | 1999-09-07 |
|---|---|
| CE Approval Date | 1998-12-17 |
| Estimated WW Distribution | 5963 |
| Normal Battery Depletions | 140 |
Malfunctions (USA)
| Therapy Function Not Compromised | 1 |
|---|---|
| Electrical Component | 1 |
| Therapy Function Compromised | 1 |
| Electrical Interconnect | 1 |
Malfunctions (WW)
| Therapy Function Not Compromised | 3 |
|---|---|
| Electrical Component | 1 |
| Electrical Interconnect | 1 |
| Other | 1 |
| Therapy Function Compromised | 6 |
| Electrical Interconnect | 6 |
Elective Replacement (ERI)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).
Data as of March 12, 2013