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 at 102.0 mo  
% Survival 99.7 99.5 99.3 99.3 99.3 99.3 98.8 98.8 98.8  
#   791 574 389 299 261 214 155 87 60  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1070
Cumulative Months of Follow-Up 39876
Number of Leads Active in Study 635
Information 6

Qualifying Complications

Conductor Fracture 1
Failure to Capture 2
Impedance Out of Range 2
Lead Dislodgement 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 at 102.0 mo  
% Survival 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1  
#   202 192 184 168 151 136 117 85 64  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 215
Cumulative Months of Follow-Up 16773
Number of Leads Active in Study 118
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 13
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 36
Failure to Sense 1
Impedance Out of Range 3
Lead Dislodgement 39
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants98308
Estimated Active USA Implants61561
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution491477
Information

USA Returned Product Analysis

Conductor Fracture 4
Insulation Breach 26
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 7
Insulation Breach 26
Crimp/Weld/Bond 0
Other 8
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
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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 August 3, 2014

www.medtronic.com/productperformance 326050