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              
% Survival 99.8 99.8 99.4              
#   2217 1243 118              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2950
Cumulative Months of Follow-Up 59779
Number of Leads Active in Study 2222
Information 7

Qualifying Complications

Failure to Capture 2
Failure to Sense 1
Impedance Out of Range 1
Lead Dislodgement 3
Other 0
ATRIAL PLACEMENT
Information

Device Survival Probability

5086MRI_ATR_SURV
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    1 yr 2 yr 3 yr              
% Survival 99.9 99.8 99.8              
#   2226 1238 122              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2961
Cumulative Months of Follow-Up 59890
Number of Leads Active in Study 2230
Information 5

Qualifying Complications

Failure to Capture 1
Impedance Out of Range 0
Lead Dislodgement 4
Other 0
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 208
Conductor Fracture 2
Extra Cardiac Stimulation 17
Failure to Capture 137
Failure to Sense 27
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 297
Oversensing 29
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants206227
Estimated Active USA Implants196468
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution355903
Information

USA Returned Product Analysis

Conductor Fracture 13
Insulation Breach 35
Crimp/Weld/Bond 0
Other 10
Information

WW Returned Product Analysis

Conductor Fracture 23
Insulation Breach 48
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 February 9, 2015

www.medtronic.com/productperformance 351052