SS203
Sigma 200 S
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 150 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 99.9 | 99.9 | 99.8 | 99.7 | 99.7 | 99.7 | 99.7 | 99.7 | 99.7 | ||||||||
| % |  |
99.9 | 99.9 | 99.8 | 99.7 | 99.2 | 98.6 | 97.2 | 95.2 | 92.3 | 86.6 | 76.2 | 65.6 | 59.6 | ||||||||
| # | 10350 | 8736 | 7434 | 6384 | 5485 | 4753 | 4061 | 3508 | 2829 | 2036 | 1245 | 457 | 110 |
- 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 | SSI |
| Max. Delivered Energy | N/A |
| Connector Style | 3.2mm Long Pin |
|---|---|
| Serial Number Prefix | PJG |
| Mass | 21.5 g |
| Volume | 10.5 cc |
| Waveform | N/A |
| X-Ray ID | PJG |
3.2mm Long Pin
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
From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 4 |
| Estimated Active USA Implants | 1 |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 20208 |
| Normal Battery Depletions | 395 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 5 |
|---|---|
| Electrical Component | 3 |
| Electrical Interconnect | 1 |
| Other | 1 |
| Therapy Function Compromised | 31 |
| Electrical Component | 1 |
| Electrical Interconnect | 30 |
Elective Replacement (ERI)
Replacement message on programmer. Nonmagnet mode VVI 65 ppm Magnet mode VOO 65 ppm
Data as of March 12, 2013