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                
% Survival 99.7 99.7 99.7 99.6 99.4 99.4 99.0 99.0 98.8 98.8 98.8 98.8 97.6                
#   1359 1174 1042 888 723 623 484 406 340 254 169 116 66                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1684
Cumulative Months of Follow-Up 101093
Number of Leads Active in Study 444
Information 11

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 5
Impedance Out of Range 2
Lead Dislodgement 1
Other 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 10 yr 11 yr 12 yr 13 yr at 162.0 mo              
% Survival 99.8 99.7 99.6 99.5 99.3 98.9 98.7 98.6 98.6 98.6 98.3 98.3 98.3 98.3              
#   2934 2531 2243 1967 1667 1399 1082 841 661 467 283 167 92 66              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3958
Cumulative Months of Follow-Up 215523
Number of Leads Active in Study 1538
Information 29

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 10
Failure to Sense 3
Impedance Out of Range 0
Insulation (not further defined) 2
Lead Dislodgement 8
Oversensing 1
Other 2
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 164
Conductor Fracture 10
Extra Cardiac Stimulation 23
Failure to Capture 220
Failure to Sense 91
Impedance Out of Range 37
Insulation Breach 1
Lead Dislodgement 583
Oversensing 76
Unspecified Clinical Failure 10
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants678898
Estimated Active USA Implants464630
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1523150
Information

USA Returned Product Analysis

Conductor Fracture 106
Insulation Breach 162
Crimp/Weld/Bond 1
Other 20
Information

WW Returned Product Analysis

Conductor Fracture 125
Insulation Breach 169
Crimp/Weld/Bond 1
Other 27
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 October 29, 2020

www.medtronic.com/productperformance 776050