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 at 102.0 mo  
% Survival 99.8 99.8 99.8 99.6 99.3 99.3 98.9 98.9 98.9  
#   1203 1017 875 718 473 287 200 104 65  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1444
Cumulative Months of Follow-Up 67467
Number of Leads Active in Study 606
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 99.7 99.6 99.5 99.4 99.1 98.7 98.4 98.4 98.4  
#   2134 1660 1300 981 585 300 212 98 55  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2762
Cumulative Months of Follow-Up 102862
Number of Leads Active in Study 1598
Information 17

Qualifying Complications

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

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 75
Conductor Fracture 4
Extra Cardiac Stimulation 12
Failure to Capture 98
Failure to Sense 27
Impedance Out of Range 13
Insulation Breach 1
Lead Dislodgement 236
Oversensing 15
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants519023
Estimated Active USA Implants361468
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1077820
Information

USA Returned Product Analysis

Conductor Fracture 62
Insulation Breach 66
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 70
Insulation Breach 70
Crimp/Weld/Bond 1
Other 34
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 November 2, 2015

www.medtronic.com/productperformance 376051