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 at 138.0 mo                  
% Survival 99.5 99.4 99.3 99.3 99.3 99.3 99.3 99.3 99.3 98.6 98.6 98.6                  
#   979 811 668 514 352 255 204 181 158 124 74 55                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1119
Cumulative Months of Follow-Up 59108
Number of Leads Active in Study 394
Information 8

Qualifying Complications

Conductor Fracture 1
Failure to Capture 2
Impedance Out of Range 1
Insulation (not further defined) 1
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                  
% 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                  
#   214 205 198 183 167 158 147 132 120 108 68 50                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 227
Cumulative Months of Follow-Up 22634
Number of Leads Active in Study 107
Information 2

Qualifying Complications

Failure to Sense 1
Lead Dislodgement 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 20
Conductor Fracture 1
Extra Cardiac Stimulation 2
Failure to Capture 66
Failure to Sense 1
Impedance Out of Range 3
Lead Dislodgement 83
Oversensing 3
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants116142
Estimated Active USA Implants66971
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution770356
Information

USA Returned Product Analysis

Conductor Fracture 8
Insulation Breach 35
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 13
Insulation Breach 38
Crimp/Weld/Bond 0
Other 10
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 July 31, 2017

www.medtronic.com/productperformance 501050