Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 76 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | |||
| % |  |
100.0 | 99.9 | 99.8 | 99.6 | 99.0 | 97.6 | 96.6 | |||
| # | 64959 | 46983 | 31651 | 18327 | 8187 | 1549 | 171 |
- 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
- There are no advisories for this model.
Product Characteristics
| Generator Type | IPG |
|---|---|
| NBD Code | SSI |
| Max. Delivered Energy | N/A |
| Connector Style | IS-1 UNI/BI |
|---|---|
| Serial Number Prefix | PWS, NWS |
| Mass | 21.5 g |
| Volume | 9.7 cc |
| Waveform | N/A |
| X-Ray ID | PWL, PWB |
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 7.4 | 8.9* | 7.9 | 9.7* |
| Nominal 3.5 V (A, RV) | 6.5 | 7.7* | 7.5 | 9.1* |
| High 5.0 V (A, RV) | 5.1 | 5.9* | 6.3 | 7.4* |
*The second longevity numbers provided apply to the N-series Sensia SES01 product. The N-series products have increased longevity because of improved electronic circuitry. Click on "Other Articles" for more information on the N-series longevity. 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 %; EGM Prestorage ON ; Upper Sensing Rate 130 ppm; EGM Prestorage ON Time 1 monthHide this content
EOS Indication
Prolonged service period is 3 months after RRT/ERI assuming 100% pacing at VVI/65 ppm at the listed parameter settings. Reprogramming of parameter settings may shorten the duration of the prolonged service period.
Distribution Data
| US Market Release | 2006-07-17 |
|---|---|
| CE Approval Date | 2005-09-20 |
| Registered USA Implants | 4 |
| Estimated Active USA Implants | 0 |
| Normal Battery Depletions |
| US Market Release | 2006-07-17 |
|---|---|
| CE Approval Date | 2005-09-20 |
| Estimated WW Distribution | 46812 |
| Normal Battery Depletions | 8 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 0 |
|---|---|
| Therapy Function Compromised | 2 |
| Battery | 1 |
| Electrical Component | 1 |
Recommended Replacement (RRT)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).
Data as of March 12, 2013