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    
% Survival 99.8 99.8 99.8 99.6 99.3 99.3 98.8 98.8    
#   1116 955 824 650 379 253 144 61    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1401
Cumulative Months of Follow-Up 61043
Number of Leads Active in Study 632
Information 7

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 3
Impedance Out of Range 2
Lead Dislodgement 1
Other 0
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 99.2 98.9 98.5 98.5    
#   1822 1466 1189 856 441 269 163 92    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2502
Cumulative Months of Follow-Up 88825
Number of Leads Active in Study 1456
Information 15

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 1
Failure to Capture 2
Failure to Sense 3
Impedance Out of Range 0
Insulation (not further defined) 1
Lead Dislodgement 6
Oversensing 1
Other 0
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 73
Conductor Fracture 4
Extra Cardiac Stimulation 11
Failure to Capture 92
Failure to Sense 25
Impedance Out of Range 12
Insulation Breach 1
Lead Dislodgement 215
Oversensing 12
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants505442
Estimated Active USA Implants382473
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution871669
Information

USA Returned Product Analysis

Conductor Fracture 57
Insulation Breach 56
Crimp/Weld/Bond 1
Other 20
Information

WW Returned Product Analysis

Conductor Fracture 65
Insulation Breach 60
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 February 9, 2015

www.medtronic.com/productperformance 351052