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 99.1 99.1 99.1  
#   1287 1104 930 775 596 420 266 183 84  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1489
Cumulative Months of Follow-Up 76821
Number of Leads Active in Study 572
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 9 yr  
% Survival 99.8 99.7 99.6 99.5 99.3 99.0 98.8 98.8 98.8  
#   2507 2060 1592 1190 860 521 292 183 73  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3031
Cumulative Months of Follow-Up 128582
Number of Leads Active in Study 1598
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 245
Oversensing 16
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants527089
Estimated Active USA Implants360778
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1111904
Information

USA Returned Product Analysis

Conductor Fracture 68
Insulation Breach 84
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 79
Insulation Breach 88
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 August 3, 2016

www.medtronic.com/productperformance 451050