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                
% Survival 99.7 99.7                
#   1439 121                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2789
Cumulative Months of Follow-Up 33141
Number of Leads Active in Study 2362
Information 6

Qualifying Complications

Failure to Capture 2
Failure to Sense 1
Lead Dislodgement 3
ATRIAL PLACEMENT
Information

Device Survival Probability

5086MRI_ATR_SURV
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    1 yr 2 yr                
% Survival 99.9 99.5                
#   1435 122                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2800
Cumulative Months of Follow-Up 33201
Number of Leads Active in Study 2372
Information 5

Qualifying Complications

Failure to Sense 1
Lead Dislodgement 4
ALL
Information

Device Survival Probability

5086MRI_SURV
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    at 0.0 mo                  

Product Surveillance Registry 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 148
Conductor Fracture 2
Extra Cardiac Stimulation 10
Failure to Capture 91
Failure to Sense 18
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 188
Oversensing 22
Information

Distribution Data

US Market Release2011-02-08
CE Approval Date2009-01-21
Registered USA Implants159331
Estimated Active USA Implants153559
US Market Release2011-02-08
CE Approval Date2009-01-21
Estimated WW Distribution291516
Information

USA Returned Product Analysis

Conductor Fracture 10
Insulation Breach 15
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 18
Insulation Breach 27
Crimp/Weld/Bond 0
Other 19
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 January 31, 2014

www.medtronic.com/productperformance 301050