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 12 yr at 150.0 mo                
% Survival 99.7 99.7 99.7 99.6 99.4 99.4 99.0 99.0 98.7 98.7 98.7 98.7 98.7                
#   1383 1191 1061 897 727 592 452 360 291 191 126 81 59                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1674
Cumulative Months of Follow-Up 98275
Number of Leads Active in Study 463
Information 11

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 5
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 11 yr 12 yr                  
% Survival 99.8 99.7 99.6 99.5 99.4 98.9 98.7 98.7 98.7 98.7 98.7 98.7                  
#   3135 2713 2343 1989 1610 1227 849 598 422 231 129 73                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3880
Cumulative Months of Follow-Up 205898
Number of Leads Active in Study 1570
Information 25

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 8
Failure to Sense 3
Impedance Out of Range 0
Insulation (not further defined) 2
Lead Dislodgement 7
Oversensing 1
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 153
Conductor Fracture 10
Extra Cardiac Stimulation 21
Failure to Capture 195
Failure to Sense 86
Impedance Out of Range 33
Insulation Breach 1
Lead Dislodgement 535
Oversensing 67
Unspecified Clinical Failure 10
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants658808
Estimated Active USA Implants452402
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1469328
Information

USA Returned Product Analysis

Conductor Fracture 100
Insulation Breach 151
Crimp/Weld/Bond 1
Other 20
Information

WW Returned Product Analysis

Conductor Fracture 119
Insulation Breach 158
Crimp/Weld/Bond 1
Other 27
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 April 10, 2020

www.medtronic.com/productperformance 751050