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 at 30.0 mo              
% Survival 99.8 99.8 99.8              
#   1966 670 198              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2937
Cumulative Months of Follow-Up 47501
Number of Leads Active in Study 2374
Information 6

Qualifying Complications

Failure to Capture 2
Failure to Sense 1
Lead Dislodgement 3
ATRIAL PLACEMENT
Information

Device Survival Probability

5086MRI_ATR_SURV
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    1 yr 2 yr at 30.0 mo              
% Survival 99.9 99.8 99.8              
#   1974 663 199              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2948
Cumulative Months of Follow-Up 47602
Number of Leads Active in Study 2378
Information 4

Qualifying Complications

Lead Dislodgement 4
ALL
Information

Device Survival Probability

5086MRI_SURV
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    at 0.0 mo                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study
Cumulative Months of Follow-Up
Number of Leads Active in Study
Information

Qualifying Complications

Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 184
Conductor Fracture 2
Extra Cardiac Stimulation 14
Failure to Capture 114
Failure to Sense 25
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 264
Oversensing 27
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants194163
Estimated Active USA Implants187031
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution339314
Information

USA Returned Product Analysis

Conductor Fracture 11
Insulation Breach 24
Crimp/Weld/Bond 0
Other 10
Information

WW Returned Product Analysis

Conductor Fracture 20
Insulation Breach 36
Crimp/Weld/Bond 0
Other 21
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 August 3, 2014

www.medtronic.com/productperformance 326050