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 at 54.0 mo          
% Survival 99.8 99.7 99.7 99.7 99.7          
#   2639 2175 1536 464 114          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3033
Cumulative Months of Follow-Up 99351
Number of Leads Active in Study 1875
Information 9

Qualifying Complications

Failure to Capture 4
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 at 54.0 mo          
% Survival 99.9 99.7 99.7 99.7 99.7          
#   2648 2187 1547 471 118          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3069
Cumulative Months of Follow-Up 99896
Number of Leads Active in Study 1907
Information 8

Qualifying Complications

Conductor Fracture 1
Failure to Capture 1
Lead Dislodgement 5
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 212
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 307
Oversensing 30
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants208046
Estimated Active USA Implants188247
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution393856
Information

USA Returned Product Analysis

Conductor Fracture 25
Insulation Breach 66
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 41
Insulation Breach 85
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 August 3, 2016

www.medtronic.com/productperformance 451050