Device Survival Probability
SEDR01_SED01_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | 14 yr | at 169.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | ||||||
| % |  |
99.9 | 99.9 | 99.8 | 99.6 | 99.3 | 98.6 | 97.3 | 93.0 | 83.1 | 69.6 | 56.3 | 45.2 | 39.4 | 37.3 | 36.7 | ||||||
| # | 120565 | 109036 | 98384 | 88751 | 80013 | 72148 | 63071 | 51398 | 37225 | 24372 | 14273 | 7242 | 3064 | 321 | 164 |
- 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 | IPG |
|---|---|
| NBD Code | DDD |
| Max. Delivered Energy | N/A |
| Connector Style | IS-1 UNI/BI |
|---|---|
| Serial Number Prefix | NWK, PWK |
| Mass | 27.1 g |
| Volume | 12.1 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 | 9.1* | 8.2 | 10.3* |
| Nominal 3.5 V (A, RV) | 6.0 | 7.2* | 7.4 | 9.0* |
| High 5.0 V (A, RV) | 4.5 | 5.1* | 6.0 | 7.0* |
*The second longevity numbers provided apply to the N-series Sensia SED01 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 DDD ; Atrial Pulse Width 0.4 ms; 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; Atrial Percent Paced 100 %; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 %Hide this content
Distribution Data
| US Market Release | 2006-07-17 |
|---|---|
| CE Approval Date | 2005-09-20 |
| Registered USA Implants | 5 |
| Estimated Active USA Implants | 1 |
| Normal Battery Depletions | 1 |
| US Market Release | 2006-07-17 |
|---|---|
| CE Approval Date | 2005-09-20 |
| Estimated WW Distribution | 65714 |
| Normal Battery Depletions | 49 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 4 |
|---|---|
| Electrical Component | 4 |
| Therapy Function Compromised | 3 |
| Electrical Component | 3 |
EOS Indication
Prolonged service period is 3 months after RRT/ERI assuming 100% VVI 65 ppm pacing at the listed parameter settings. Reprogramming of parameters can reduce the prolonged service period.
Recommended Replacement (RRT)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).
Data as of November 29, 2022