Device Survival Probability
ADDR01_ADDR03_ADDR06_ADD01_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | at 131.0 mo | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | ||||||||||
| % |  |
99.9 | 99.8 | 99.8 | 99.7 | 99.4 | 99.0 | 98.0 | 93.9 | 82.5 | 60.7 | 34.6 | ||||||||||
| # | 406164 | 381018 | 352493 | 320552 | 288110 | 247800 | 203526 | 152893 | 93796 | 34888 | 994 |
- 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 | PWF, NWF |
| Mass | 27.1 g |
| Volume | 12.1 cc |
| Waveform | N/A |
| X-Ray ID | PWB, NWF |
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 Adapta ADD01 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 | 1 |
| Estimated Active USA Implants | 0 |
| Normal Battery Depletions |
| US Market Release | 2006-07-17 |
|---|---|
| CE Approval Date | 2005-09-20 |
| Estimated WW Distribution | 31349 |
| Normal Battery Depletions | 42 |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 1 |
|---|---|
| Electrical Component | 1 |
| Therapy Function Compromised | 1 |
| Electrical Component | 1 |
EOS Indication
The 3 month prolonged service period between RRT/ERI and EOS assumes 100% pacing in VVI mode, rate of 65 ppm, RV Amplitude of 3.5 V, RV Pulse Width of 0.4 ms, and pacing load of 500 OHMS;. Reprogramming the pacing parameters may reduce the duration of the prolonged service period.
Recommended Replacement (RRT)
Telemetry indication. Rate and mode change to 65 ppm and VVI respectively (VOO/65 with magnet).
Data as of November 8, 2019