4074 CapSure Sense
Pacing
4074 CapSure Sense
VENTRICULAR PLACEMENT
Information

Device Survival Probability

4074_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 16 yr 17 yr 18 yr at 222.0 mo    
% Survival 99.5 99.3 99.2 99.2 99.2 99.2 99.2 99.2 99.2 98.8 98.8 97.7 97.7 96.9 96.9 96.9 96.9 96.9 96.9    
#   1031 882 742 640 500 414 352 302 264 224 196 167 133 127 114 92 77 65 55    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1192
Cumulative Months of Follow-Up 83538
Number of Leads Active in Study 73
Information 12

Qualifying Complications

Conductor Fracture 1
Failure to Capture 4
Impedance Out of Range 2
Insulation (not further defined) 2
Lead Dislodgement 2
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability

4074_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 16 yr 17 yr 18 yr at 222.0 mo    
% Survival 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1    
#   214 205 198 183 167 158 148 136 126 117 110 107 99 96 90 78 71 56 52    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 227
Cumulative Months of Follow-Up 30578
Number of Leads Active in Study 34
Information 2

Qualifying Complications

Failure to Sense 1
Lead Dislodgement 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 41
Conductor Fracture 2
Extra Cardiac Stimulation 4
Failure to Capture 215
Failure to Sense 19
Impedance Out of Range 22
Lead Dislodgement 222
Oversensing 9
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants163354
Estimated Active USA Implants80215
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution1158464
Information

USA Returned Product Analysis

Conductor Fracture 17
Insulation Breach 67
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 24
Insulation Breach 73
Crimp/Weld/Bond 0
Other 5
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix BBD
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) Silicone (inner)
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of June 8, 2026

www.medtronic.com/productperformance 22521