ATDRS1
Attesta S DR MRI
Device Survival Probability
ATDRS1_SURV
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| 1 yr | at 23.0 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | ||||||||
| % |  |
100.0 | 100.0 | ||||||||
| # | 441 | 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.
Customer Communications For This Model
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Product Characteristics
| Generator Type | IPG |
|---|---|
| NBD Code | DDDR |
| Max. Delivered Energy | N/A |
| Connector Style | IS-1 UNI/BI |
|---|---|
| Serial Number Prefix | FNA |
| Mass | 23.6 g |
| Volume | 11.1 cc |
| Waveform | N/A |
| X-Ray ID | PHX |
IS-1 UNI/BI
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 7.2 | 8.3 |
| Nominal 3.5 V (A, RV) | 5.5 | 7.1 |
| High 5.0 V (A, RV) | 3.8 | 5.4 |
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 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Atrial Fib Percent of Time 0 % Hide this content
Distribution Data
| US Market Release | 2017-08-03 |
|---|---|
| CE Approval Date | 2017-06-16 |
| Registered USA Implants | 872 |
| Estimated Active USA Implants | 817 |
| Normal Battery Depletions |
| US Market Release | 2017-08-03 |
|---|---|
| CE Approval Date | 2017-06-16 |
| Estimated WW Distribution | 5144 |
| Normal Battery Depletions |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
EOL Indicator
180 days from RRT
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.5 V, or battery voltage less than or equal to 2.59 V and battery impedance at 3000 ohms
Data as of May 10, 2023