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 10 yr
% Survival 99.8 99.8 99.8 99.7 99.4 99.4 98.9 98.9 98.9 98.9
#   1297 1135 965 786 611 493 288 197 126 59

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1507
Cumulative Months of Follow-Up 80506
Number of Leads Active in Study 537
Information 8

Qualifying Complications

Conductor Fracture 1
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 at 114.0 mo
% Survival 99.8 99.7 99.6 99.4 99.3 99.0 98.9 98.9 98.9 98.9
#   2629 2203 1752 1308 952 664 348 216 119 72

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3143
Cumulative Months of Follow-Up 140663
Number of Leads Active in Study 1592
Information 17

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 3
Failure to Sense 3
Impedance Out of Range 0
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 85
Conductor Fracture 5
Extra Cardiac Stimulation 13
Failure to Capture 105
Failure to Sense 31
Impedance Out of Range 14
Insulation Breach 1
Lead Dislodgement 259
Oversensing 16
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants540878
Estimated Active USA Implants369150
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1144084
Information

USA Returned Product Analysis

Conductor Fracture 76
Insulation Breach 90
Crimp/Weld/Bond 1
Other 21
Information

WW Returned Product Analysis

Conductor Fracture 88
Insulation Breach 95
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 February 3, 2017

www.medtronic.com/productperformance 476050