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 99.8 99.7 99.3 99.3 98.6 98.6    
#   1079 943 792 569 343 228 101 75    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1374
Cumulative Months of Follow-Up 57152
Number of Leads Active in Study 682
Information 6

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 3
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 99.3 99.1 98.8 98.3 98.3    
#   1541 1301 1055 708 372 240 104 63    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2185
Cumulative Months of Follow-Up 75884
Number of Leads Active in Study 1243
Information 14

Qualifying Complications

Conductor Fracture 1
Failure to Capture 2
Failure to Sense 3
Insulation (not further defined) 1
Lead Dislodgement 6
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 64
Conductor Fracture 4
Extra Cardiac Stimulation 10
Failure to Capture 80
Failure to Sense 24
Impedance Out of Range 12
Insulation Breach 1
Lead Dislodgement 198
Oversensing 11
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants491687
Estimated Active USA Implants377938
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution845757
Information

USA Returned Product Analysis

Conductor Fracture 51
Insulation Breach 52
Crimp/Weld/Bond 1
Other 20
Information

WW Returned Product Analysis

Conductor Fracture 58
Insulation Breach 56
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 August 3, 2014

www.medtronic.com/productperformance 326050