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 at 102.0 mo  
% Survival 99.7 99.7 99.6 99.6 99.6 99.1 98.0 97.6 97.6  
#   2532 2188 1856 1433 734 401 311 199 108  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3059
Cumulative Months of Follow-Up 132885
Number of Leads Active in Study 1417
Information 20

Qualifying Complications

Conductor Fracture 2
Failure to Capture 9
Failure to Sense 1
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 at 102.0 mo  
% Survival 99.8 99.6 99.6 99.4 99.3 98.9 98.3 98.3 98.3  
#   2535 2208 1883 1466 761 430 322 206 109  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3120
Cumulative Months of Follow-Up 134691
Number of Leads Active in Study 1433
Information 20

Qualifying Complications

Conductor Fracture 3
Failure to Capture 3
Impedance Out of Range 0
Lead Dislodgement 11
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 2
Extra Cardiac Stimulation 18
Failure to Capture 142
Failure to Sense 28
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 310
Oversensing 31
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants208670
Estimated Active USA Implants132388
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution398394
Information

USA Returned Product Analysis

Conductor Fracture 98
Insulation Breach 176
Crimp/Weld/Bond 0
Other 11
Information

WW Returned Product Analysis

Conductor Fracture 122
Insulation Breach 197
Crimp/Weld/Bond 0
Other 16
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 October 11, 2021

www.medtronic.com/productperformance 826050