EMDR01
EnRhythm MRI
Device Survival Probability
| 1 yr | 2 yr | 3 yr | at 41 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | ||||||
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | ||||||
| # | 155 | 147 | 120 | 100 |
- 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 | DDDRP |
| Max. Delivered Energy | N/A |
| Connector Style | IS-1 UNI/BI |
|---|---|
| Serial Number Prefix | PTA |
| Mass | 21.5 g |
| Volume | 12.7 cc |
| Waveform | N/A |
| X-Ray ID | PTA and MRI symbol |
IS-1 UNI/BI
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 9.7 | 11.2 |
| Nominal 3.5 V (A, RV) | 7.3 | 9.4 |
| High 5.0 V (A, RV) | 4.9 | 7.1 |
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
EOS Indication
From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.
Distribution Data
| US Market Release | |
|---|---|
| CE Approval Date | 2008-09-30 |
| Registered USA Implants | 110 |
| Estimated Active USA Implants | 83 |
| Normal Battery Depletions |
| US Market Release | |
|---|---|
| CE Approval Date | 2008-09-30 |
| Estimated WW Distribution | 5147 |
| Normal Battery Depletions |
Malfunctions (USA)
| Therapy Function Not Compromised | 6 |
|---|---|
| Battery | 6 |
| Therapy Function Compromised | 0 |
Malfunctions (WW)
| Therapy Function Not Compromised | 62 |
|---|---|
| Battery | 49 |
| Electrical Component | 2 |
| Possible Early Battery Depletion | 1 |
| Other | 10 |
| Therapy Function Compromised | 3 |
| Electrical Component | 1 |
| Possible Early Battery Depletion | 2 |
Recommended Replacement (RRT)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).
Data as of March 12, 2013