MC1VR01
Micra VR
Device Survival Probability
MC1VR01_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 81.0 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.9 | 99.9 | 99.8 | 99.8 | 99.7 | 99.6 | 99.6 | |||
| % |  |
99.9 | 99.7 | 99.3 | 98.9 | 98.1 | 96.3 | 92.5 | |||
| # | 36416 | 25304 | 16056 | 9358 | 3952 | 1067 | 139 |
- 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 | TPS |
|---|---|
| NBD Code | VVIR |
| Max. Delivered Energy | N/A |
| Serial Number Prefix | MCR |
|---|---|
| Mass | 1.75 g |
| Volume | 1 cc |
| Waveform | N/A |
| X-Ray ID | Medtronic Logo |
CareLink Population
| Enrolled | 45764 |
|---|---|
| Active | 31467 |
| Cumulative Follow-Up Months | 1335166 |
| Normal Battery Depletion | 254 |
70
CareLink Qualifying Malfunctions/Complications
| Cardiac Perforation | 7 |
|---|---|
| Dislodgements | 2 |
| Elevated Pacing Threshold | 41 |
| Failure to Capture | 8 |
| Premature Battery Depletion | 12 |
Distribution Data
| US Market Release | 2016-04-06 |
|---|---|
| CE Approval Date | 2015-04-14 |
| Registered USA Implants | 72237 |
| US Market Release | 2016-04-06 |
|---|---|
| CE Approval Date | 2015-04-14 |
| Estimated WW Distribution | 158457 |
*Acute Observations (N = 72237)
| Cardiac Perforation | 21 |
|---|---|
| Dislodgement | 22 |
| Elevated Pacing Threshold | 165 |
| Failure to Capture | 80 |
| Failure to Sense | 17 |
*Day of Implant Observations (N = 72237)
| Cardiac Perforation | 290 |
|---|---|
| Dislodgement | 172 |
| Elevated Pacing Threshold | 261 |
| Failure to Capture | 129 |
| Failure to Sense | 72 |
The rate of perforation for commercially released Micra VR devices continues to perform acceptably within levels observed within the post-approval clinical study registry. Overall, clinical studies have demonstrated a reduction in the risk of major complications of 63% through 12 months1 and 57% through 36 months2 relative to transvenous pacing systems.
EOS Indicator
From the point that the RRT is set, the pacemaker will operate for approximately six months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
6 months before battery voltage measures less than or equal to 2.5V on 3 consecutive daily automatic measurements.
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 700 Lead Ω |
|---|---|---|
| Low 1.0 V | 12.17 | 12.8 |
| Nominal 2.0 V | 7.9 | 9.1 |
| High 2.5 V | 6.5 | 7.6 |
Longevity estimates based on the following device usage. Pace/Sense Mode VVI Right Ventricle Pulse Width 0.24 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; VCM Mode: Adaptive, 0.5 , 1.0 PSF Hide this content
1. El-Chami et al. Heart Rhythm 2018 15(12): 1800-1807.
2. Piccini et al. Heart Rhythm 2020 17(5 Supplement) D-PO02-089
* Data in these tables is sourced direct from the MDT complaint handling database summarizing observations reported to Medtronic relative to the registered US implant population.
Data as of April 30, 2024