EN1DR01
Ensura MRI
Device Survival Probability
| 1 yr | 2 yr | at 35 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | |||||||
| % |  |
100.0 | 100.0 | 100.0 | |||||||
| # | 7227 | 3086 | 129 |
- 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 | OOE-DDDR |
| Max. Delivered Energy | N/A |
| Connector Style | IS-1 UNI/BI |
|---|---|
| Serial Number Prefix | PZW |
| Mass | 22g |
| Volume | 12.7cc |
| Waveform | N/A |
| X-Ray ID | PVX |
IS-1 UNI/BI
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 8.9 | 10.2 |
| Nominal 3.5 V (A, RV) | 6.9 | 8.6 |
| High 5.0 V (A, RV) | 4.3 | 6.2 |
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
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 24582 |
| Normal Battery Depletions |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | 5 |
|---|---|
| Electrical Component | 3 |
| Other | 2 |
| Therapy Function Compromised | 1 |
| Electrical Component | 1 |
Recommended Replacement (RRT)
Data as of March 12, 2013