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 at 90.0 mo    
% Survival 99.8 99.8 99.7 99.6 99.1 99.1 98.3 98.3    
#   1062 930 747 470 314 203 83 65    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1352
Cumulative Months of Follow-Up 53549
Number of Leads Active in Study 705
Information 7

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 4
Impedance Out of Range 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 at 90.0 mo    
% Survival 99.7 99.6 99.4 99.1 98.9 98.1 97.6 97.6    
#   1443 1242 979 552 332 210 79 56    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2010
Cumulative Months of Follow-Up 68409
Number of Leads Active in Study 1148
Information 15

Qualifying Complications

Conductor Fracture 1
Failure to Capture 2
Failure to Sense 6
Insulation (not further defined) 1
Lead Dislodgement 4
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 58
Conductor Fracture 4
Extra Cardiac Stimulation 10
Failure to Capture 78
Failure to Sense 21
Impedance Out of Range 12
Insulation Breach 1
Lead Dislodgement 152
Oversensing 7
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants470611
Estimated Active USA Implants360424
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution803893
Information

USA Returned Product Analysis

Conductor Fracture 44
Insulation Breach 39
Crimp/Weld/Bond 1
Other 21
Information

WW Returned Product Analysis

Conductor Fracture 51
Insulation Breach 43
Crimp/Weld/Bond 1
Other 32
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 January 31, 2014

www.medtronic.com/productperformance 301050