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                    
% Survival 99.8 99.8 99.8 99.7 99.4 99.4 99.0 99.0 98.7 98.7 98.7                    
#   1319 1167 1039 869 653 542 427 317 192 120 73                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1570
Cumulative Months of Follow-Up 89859
Number of Leads Active in Study 443
Information 10

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 4
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                    
% Survival 99.8 99.7 99.6 99.5 99.4 99.0 98.9 98.9 98.9 98.9 98.9                    
#   2897 2519 2169 1768 1288 905 652 425 227 132 63                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3453
Cumulative Months of Follow-Up 176180
Number of Leads Active in Study 1467
Information 19

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 5
Failure to Sense 3
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 111
Conductor Fracture 6
Extra Cardiac Stimulation 17
Failure to Capture 145
Failure to Sense 57
Impedance Out of Range 24
Insulation Breach 1
Lead Dislodgement 376
Oversensing 42
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants598958
Estimated Active USA Implants416122
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1296762
Information

USA Returned Product Analysis

Conductor Fracture 89
Insulation Breach 124
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 105
Insulation Breach 130
Crimp/Weld/Bond 1
Other 36
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 12, 2018

www.medtronic.com/productperformance 626050