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  
% Survival 99.8 99.8 99.8 99.7 99.4 99.4 99.0 99.0 99.0  
#   1265 1060 903 747 545 347 242 155 66  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1470
Cumulative Months of Follow-Up 72817
Number of Leads Active in Study 592
Information 7

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 3
Impedance Out of Range 2
Lead Dislodgement 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 at 102.0 mo  
% Survival 99.8 99.7 99.5 99.4 99.2 98.9 98.7 98.7 98.7  
#   2383 1898 1456 1109 740 393 257 149 90  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2949
Cumulative Months of Follow-Up 118023
Number of Leads Active in Study 1666
Information 16

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 1
Failure to Capture 3
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 78
Conductor Fracture 5
Extra Cardiac Stimulation 12
Failure to Capture 101
Failure to Sense 28
Impedance Out of Range 13
Insulation Breach 1
Lead Dislodgement 243
Oversensing 16
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants524419
Estimated Active USA Implants361111
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1097287
Information

USA Returned Product Analysis

Conductor Fracture 63
Insulation Breach 77
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 72
Insulation Breach 81
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 April 14, 2016

www.medtronic.com/productperformance 426050