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            
% Survival 99.8 99.8 99.7 99.7            
#   2547 1924 1063 96            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2964
Cumulative Months of Follow-Up 84785
Number of Leads Active in Study 1992
Information 7

Qualifying Complications

Failure to Capture 2
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            
% Survival 99.9 99.8 99.8 99.8            
#   2556 1934 1067 101            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2982
Cumulative Months of Follow-Up 85145
Number of Leads Active in Study 2012
Information 6

Qualifying Complications

Failure to Capture 1
Lead Dislodgement 5
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 Implants208110
Estimated Active USA Implants189279
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution392820
Information

USA Returned Product Analysis

Conductor Fracture 23
Insulation Breach 53
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 36
Insulation Breach 72
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 April 14, 2016

www.medtronic.com/productperformance 426050