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 at 162.0 mo              
% 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 97.5 97.5              
#   1380 1197 1047 896 727 632 504 414 347 273 197 125 86 64              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1698
Cumulative Months of Follow-Up 103442
Number of Leads Active in Study 426
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              
% Survival 99.8 99.7 99.6 99.5 99.3 98.9 98.8 98.7 98.7 98.7 98.2 98.2 98.2 96.7              
#   3024 2595 2279 2003 1719 1451 1193 911 705 522 333 189 124 54              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4044
Cumulative Months of Follow-Up 224647
Number of Leads Active in Study 1536
Information 31

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 2
Failure to Capture 10
Failure to Sense 3
Impedance Out of Range 0
Insulation (not further defined) 2
Lead Dislodgement 8
Oversensing 1
Other 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 188
Conductor Fracture 11
Extra Cardiac Stimulation 25
Failure to Capture 260
Failure to Sense 113
Impedance Out of Range 42
Insulation Breach 1
Lead Dislodgement 692
Oversensing 93
Unspecified Clinical Failure 10
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants722569
Estimated Active USA Implants391720
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1680570
Information

USA Returned Product Analysis

Conductor Fracture 114
Insulation Breach 186
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 135
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 October 11, 2021

www.medtronic.com/productperformance 826050