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 11 yr 12 yr 13 yr 14 yr 15 yr at 186.0 mo          
% Survival 99.7 99.7 99.7 99.6 99.3 99.3 99.0 99.0 98.8 98.5 98.5 98.5 97.9 97.9 97.9 97.9          
#   1427 1271 1125 943 753 657 551 472 391 322 266 209 148 104 69 53          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1746
Cumulative Months of Follow-Up 114067
Number of Leads Active in Study 366
Information 14

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 1
Impedance Out of Range 2
Lead Dislodgement 1
Other 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 8 yr 9 yr 10 yr 11 yr 12 yr 13 yr 14 yr 15 yr at 186.0 mo          
% Survival 99.7 99.6 99.6 99.5 99.3 98.9 98.8 98.7 98.7 98.7 98.4 98.4 98.4 96.9 96.9 96.9          
#   3318 2910 2527 2165 1850 1604 1412 1203 974 725 546 391 243 152 99 76          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4529
Cumulative Months of Follow-Up 263099
Number of Leads Active in Study 1626
Information 37

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 3
Failure to Capture 10
Failure to Sense 3
Impedance Out of Range 0
Insulation (not further defined) 3
Lead Dislodgement 12
Oversensing 2
Other 2
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 234
Conductor Fracture 11
Extra Cardiac Stimulation 28
Failure to Capture 337
Failure to Sense 185
Impedance Out of Range 64
Insulation Breach 2
Lead Dislodgement 827
Oversensing 119
Unspecified Clinical Failure 10
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants777799
Estimated Active USA Implants439266
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1941695
Information

USA Returned Product Analysis

Conductor Fracture 125
Insulation Breach 206
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 147
Insulation Breach 217
Crimp/Weld/Bond 1
Other 31
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 May 10, 2023

www.medtronic.com/productperformance 926050