4076 CapSureFix Novus
Pacing
4076 CapSureFix Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

4076_VEN_SURV
Loading...











    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 98.0 98.0 98.0 98.0          
#   1443 1286 1136 963 769 666 558 481 413 327 275 221 172 115 82 69          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1760
Cumulative Months of Follow-Up 116900
Number of Leads Active in Study 351
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
Loading...











    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 16 yr          
% Survival 99.7 99.6 99.6 99.5 99.4 99.0 98.9 98.8 98.8 98.8 98.5 98.5 98.5 97.3 97.3 97.3          
#   3400 2963 2583 2216 1879 1628 1433 1230 1022 787 576 426 301 184 118 64          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4720
Cumulative Months of Follow-Up 271871
Number of Leads Active in Study 1682
Information 36

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 3
Failure to Capture 9
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 245
Conductor Fracture 11
Extra Cardiac Stimulation 27
Failure to Capture 370
Failure to Sense 258
Impedance Out of Range 68
Insulation Breach 2
Lead Dislodgement 875
Oversensing 140
Unspecified Clinical Failure 10
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants801663
Estimated Active USA Implants459590
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution2022809
Information

USA Returned Product Analysis

Conductor Fracture 130
Insulation Breach 217
Crimp/Weld/Bond 2
Other 23
Information

WW Returned Product Analysis

Conductor Fracture 154
Insulation Breach 228
Crimp/Weld/Bond 2
Other 33
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
Hide this content

Data as of December 1, 2023

www.medtronic.com/productperformance 951051