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 | 100.0 | 99.8 | 99.6 | 99.1 | 98.5 | 98.3 | |||
| # | 97715 | 75243 | 53832 | 33391 | 15933 | 3272 | 544 |
- 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 | DDDR |
| Max. Delivered Energy | N/A |
| Connector Style | IS-1 UNI/BI |
|---|---|
| Serial Number Prefix | NWL, PWL |
| 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 SEDR01 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
EOS Indication
The prolonged service period is 3 months after RRT/ERI and assumes 100% pacing at VVI/65 and the listed parameter values. Reprogramming of parameters 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 | 119088 |
| Estimated Active USA Implants | 90082 |
| Normal Battery Depletions | 171 |
| US Market Release | 2006-07-17 |
|---|---|
| CE Approval Date | 2005-09-20 |
| Estimated WW Distribution | 324336 |
| Normal Battery Depletions | 183 |
Malfunctions (USA)
| Therapy Function Not Compromised | 14 |
|---|---|
| Electrical Component | 11 |
| Electrical Interconnect | 1 |
| Other | 2 |
| Therapy Function Compromised | 10 |
| Electrical Component | 4 |
| Electrical Interconnect | 1 |
| Other | 5 |
Malfunctions (WW)
| Therapy Function Not Compromised | 39 |
|---|---|
| Electrical Component | 32 |
| Electrical Interconnect | 1 |
| Other | 6 |
| Therapy Function Compromised | 16 |
| Electrical Component | 9 |
| Electrical Interconnect | 2 |
| Other | 5 |
Recommended Replacement (RRT)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).
Data as of March 12, 2013