4076 CapSureFix Novus
Pacing
4076 CapSureFix Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

4076_VEN_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr                    
% Survival 99.8 99.8 99.8 99.7 99.4 99.4 99.0 99.0 98.6 98.6 98.6                    
#   1311 1160 1030 837 638 535 409 259 177 107 51                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1535
Cumulative Months of Follow-Up 87096
Number of Leads Active in Study 450
Information 9

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 3
Impedance Out of Range 2
Lead Dislodgement 1
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability

4076_ATR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr at 126.0 mo                    
% Survival 99.8 99.7 99.6 99.5 99.3 99.1 99.0 99.0 99.0 99.0 99.0                    
#   2812 2431 2058 1620 1143 832 582 314 196 112 67                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3341
Cumulative Months of Follow-Up 164633
Number of Leads Active in Study 1487
Information 18

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 4
Failure to Sense 3
Insulation (not further defined) 2
Lead Dislodgement 5
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 101
Conductor Fracture 5
Extra Cardiac Stimulation 17
Failure to Capture 134
Failure to Sense 51
Impedance Out of Range 18
Insulation Breach 1
Lead Dislodgement 339
Oversensing 34
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants580077
Estimated Active USA Implants399644
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1244009
Information

USA Returned Product Analysis

Conductor Fracture 84
Insulation Breach 112
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 99
Insulation Breach 117
Crimp/Weld/Bond 1
Other 35
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 BBL
Lead Body Diameter 5.7 FR
Insulation Polyurethane/Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of January 31, 2018

www.medtronic.com/productperformance 601051