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 at 42.0 mo            
% Survival 99.8 99.8 99.7 99.7            
#   2448 1703 556 157            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2958
Cumulative Months of Follow-Up 73634
Number of Leads Active in Study 2075
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 at 42.0 mo            
% Survival 99.9 99.7 99.7 99.7            
#   2456 1704 554 154            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2972
Cumulative Months of Follow-Up 73763
Number of Leads Active in Study 2083
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 210
Conductor Fracture 2
Extra Cardiac Stimulation 17
Failure to Capture 139
Failure to Sense 28
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 305
Oversensing 30
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants207734
Estimated Active USA Implants190419
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution390754
Information

USA Returned Product Analysis

Conductor Fracture 21
Insulation Breach 46
Crimp/Weld/Bond 0
Other 11
Information

WW Returned Product Analysis

Conductor Fracture 33
Insulation Breach 63
Crimp/Weld/Bond 0
Other 22
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 November 2, 2015

www.medtronic.com/productperformance 376051