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
% Survival 99.5 99.4 99.2 99.2 99.2 99.2 99.2 99.2 99.2 98.6  
#   951 781 610 447 314 239 198 179 150 102 62

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1108
Cumulative Months of Follow-Up 55235
Number of Leads Active in Study 431
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
% Survival 99.6 99.6 99.6 99.6 99.6 99.6 99.6 99.6 99.6 99.6  
#   214 205 198 179 162 154 146 131 118 87 60

Product Surveillance Registry Results

Number of Leads Enrolled in Study 227
Cumulative Months of Follow-Up 21793
Number of Leads Active in Study 114
Information 1

Qualifying Complications

Failure to Sense 1
Impedance Out of Range 0
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 19
Conductor Fracture 1
Extra Cardiac Stimulation 2
Failure to Capture 60
Failure to Sense 1
Impedance Out of Range 3
Lead Dislodgement 70
Oversensing 3
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants110136
Estimated Active USA Implants62324
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution728676
Information

USA Returned Product Analysis

Conductor Fracture 8
Insulation Breach 34
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 13
Insulation Breach 37
Crimp/Weld/Bond 0
Other 9
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 February 3, 2017

www.medtronic.com/productperformance 476050