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 13 yr 14 yr              
% Survival 99.7 99.7 99.7 99.6 99.4 99.4 99.0 99.0 98.8 98.5 98.5 98.5 97.6 97.6              
#   1393 1227 1063 903 731 640 528 424 358 295 233 138 104 63              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1713
Cumulative Months of Follow-Up 106524
Number of Leads Active in Study 408
Information 13

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 5
Failure to Sense 1
Impedance Out of Range 2
Lead Dislodgement 1
Other 2
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 13 yr 14 yr at 174.0 mo            
% Survival 99.8 99.7 99.6 99.5 99.3 98.9 98.8 98.7 98.7 98.7 98.3 98.3 98.3 96.5 96.5            
#   3128 2691 2317 2050 1756 1502 1277 992 751 594 417 229 153 83 53            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4115
Cumulative Months of Follow-Up 235332
Number of Leads Active in Study 1503
Information 33

Qualifying Complications

Cardiac Perforation 3
Conductor Fracture 2
Failure to Capture 10
Failure to Sense 3
Impedance Out of Range 0
Insulation (not further defined) 2
Lead Dislodgement 9
Oversensing 1
Other 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 192
Conductor Fracture 10
Extra Cardiac Stimulation 25
Failure to Capture 266
Failure to Sense 115
Impedance Out of Range 44
Insulation Breach 1
Lead Dislodgement 713
Oversensing 94
Unspecified Clinical Failure 10
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants729812
Estimated Active USA Implants397689
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1707027
Information

USA Returned Product Analysis

Conductor Fracture 115
Insulation Breach 186
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 136
Insulation Breach 195
Crimp/Weld/Bond 1
Other 30
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 December 16, 2021

www.medtronic.com/productperformance 851050