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 at 66.0 mo        
% Survival 99.8 99.7 99.6 99.5 99.5 99.5        
#   2660 2298 1900 1334 399 73        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3036
Cumulative Months of Follow-Up 120669
Number of Leads Active in Study 1616
Information 11

Qualifying Complications

Conductor Fracture 1
Failure to Capture 5
Failure to Sense 1
Impedance Out of Range 1
Lead Dislodgement 3
ATRIAL PLACEMENT
Information

Device Survival Probability

5086MRI_ATR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 66.0 mo        
% Survival 99.8 99.6 99.6 99.5 99.5 99.5        
#   2677 2305 1916 1340 396 73        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3092
Cumulative Months of Follow-Up 121298
Number of Leads Active in Study 1649
Information 14

Qualifying Complications

Conductor Fracture 2
Failure to Capture 1
Lead Dislodgement 10
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 17
Failure to Capture 140
Failure to Sense 28
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 308
Oversensing 30
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants208433
Estimated Active USA Implants185031
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution395154
Information

USA Returned Product Analysis

Conductor Fracture 47
Insulation Breach 89
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 67
Insulation Breach 108
Crimp/Weld/Bond 0
Other 23
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 July 31, 2017

www.medtronic.com/productperformance 501050