5086MRI CapsureFix Novus MRI
Pacing
5086MRI CapsureFix Novus MRI
VENTRICULAR PLACEMENT
Information

Device Survival Probability


5086MRI_VEN_SURV
    1 yr at 15 mo                
% Survival 99.9 99.9                
#   181 56                

System Longevity Study Results

Number of Leads Enrolled in Study 2397
Cumulative Months of Follow-Up 13008
Number of Leads Active in Study 2220
Information 2

Qualifying Complications

Failure to Capture 1
Lead Dislodgement 1
ATRIAL PLACEMENT
Information

Device Survival Probability


5086MRI_ATR_SURV
    1 yr at 15 mo                
% Survival 99.9 99.9                
#   182 56                

System Longevity Study Results

Number of Leads Enrolled in Study 2406
Cumulative Months of Follow-Up 13080
Number of Leads Active in Study 2225
Information 1

Qualifying Complications

Lead Dislodgement 1
ALL
Information

Device Survival Probability


5086MRI_SURV
    1 yr                  
% Survival 100.0                  
#   64                  

System Longevity Study 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 99
Conductor Fracture 2
Extra Cardiac Stimulation 9
Failure to Capture 55
Failure to Sense 11
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 112
Oversensing 13
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants102899
Estimated Active USA Implants99717
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution196814
Information

USA Returned Product Analysis

Conductor Fracture 3
Insulation Breach 3
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 11
Insulation Breach 11
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 March 12, 2013

www.medtronic.com/productperformance 251050