5086MRI CapsureFix Novus MRI
Pacing
5086MRI CapsureFix Novus MRI
VENTRICULAR PLACEMENT
Information

Device Survival Probability

5086MRI_VEN_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr 13 yr                
% Survival 99.7 99.7 99.6 99.6 99.6 99.3 98.3 98.0 98.0 98.0 98.0 97.6 97.6                
#   2525 2182 1850 1425 734 422 374 331 300 277 212 131 62                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3072
Cumulative Months of Follow-Up 146399
Number of Leads Active in Study 1231
Information 21

Qualifying Complications

Conductor Fracture 3
Failure to Capture 8
Failure to Sense 2
Impedance Out of Range 2
Lead Dislodgement 3
Oversensing 2
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability

5086MRI_ATR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr 13 yr                
% Survival 99.8 99.6 99.6 99.4 99.3 98.9 98.4 98.4 98.4 98.1 98.1 98.1 98.1                
#   2528 2202 1878 1460 766 453 398 354 320 296 230 141 64                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3142
Cumulative Months of Follow-Up 149577
Number of Leads Active in Study 1250
Information 21

Qualifying Complications

Conductor Fracture 3
Failure to Capture 3
Lead Dislodgement 12
Oversensing 2
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 213
Conductor Fracture 4
Extra Cardiac Stimulation 18
Failure to Capture 144
Failure to Sense 29
Impedance Out of Range 9
Insulation Breach 2
Lead Dislodgement 312
Oversensing 32
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants207830
Estimated Active USA Implants124401
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution398387
Information

USA Returned Product Analysis

Conductor Fracture 124
Insulation Breach 230
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 148
Insulation Breach 253
Crimp/Weld/Bond 0
Other 17
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Active Screw In
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium or Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LFP
Lead Body Diameter 6.9 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of December 1, 2025

www.medtronic.com/productperformance 22021