RVDR01 Revo MRI SureScan
Implantable Pulse Generator (IPG)
RVDR01 Revo MRI SureScan
Information

Device Survival Probability

RVDR01_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 78.0 mo      
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.9 99.8      
% Including Normal Battery Depletion 100.0 99.9 99.9 99.8 99.6 99.2 96.5      
#   60709 57035 53573 49241 33999 10557 319      
  • 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.
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type IPG
NBD Code DDDRP
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PTN
Mass 21.5 g
Volume 12.7 cc
Waveform N/A
X-Ray ID PTA and MRI symbol
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IS-1 UNI/BI
Information

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
Footnote

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

Information

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.

Information

Distribution Data

US Market Release2011-02-08
CE Approval Date
Registered USA Implants68631
Estimated Active USA Implants58378
Normal Battery Depletions124
US Market Release2011-02-08
CE Approval Date
Estimated WW Distribution69387
Normal Battery Depletions124
Information

Malfunctions (USA)

Therapy Function Not Compromised 52
Battery 1
Electrical Component 32
Possible Early Battery Depletion 16
Software/Firmware 3
Therapy Function Compromised 3
Electrical Component 3
Information

Malfunctions (WW)

Therapy Function Not Compromised 54
Battery 1
Electrical Component 34
Possible Early Battery Depletion 16
Software/Firmware 3
Therapy Function Compromised 3
Electrical Component 3
Information

Recommended Replacement (RRT)

Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).

Data as of July 31, 2017

www.medtronic.com/productperformance 501050