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      
% Survival 99.7 99.7 99.6 99.6 99.6 99.6 96.3      
#   2625 2208 1852 1403 618 192 58      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3049
Cumulative Months of Follow-Up 124788
Number of Leads Active in Study 1502
Information 16

Qualifying Complications

Conductor Fracture 1
Failure to Capture 8
Failure to Sense 1
Impedance Out of Range 1
Lead Dislodgement 3
Oversensing 2
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      
% Survival 99.8 99.6 99.6 99.4 99.4 99.4 98.5      
#   2651 2227 1865 1413 631 198 55      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3102
Cumulative Months of Follow-Up 125924
Number of Leads Active in Study 1526
Information 16

Qualifying Complications

Conductor Fracture 3
Failure to Capture 1
Lead Dislodgement 11
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 214
Conductor Fracture 2
Extra Cardiac Stimulation 18
Failure to Capture 140
Failure to Sense 28
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 309
Oversensing 31
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants208575
Estimated Active USA Implants182692
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution395147
Information

USA Returned Product Analysis

Conductor Fracture 70
Insulation Breach 122
Crimp/Weld/Bond 0
Other 11
Information

WW Returned Product Analysis

Conductor Fracture 93
Insulation Breach 142
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 April 11, 2019

www.medtronic.com/productperformance 651050