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 99.5 99.4 99.2 99.2 99.2 99.2 99.2 99.2 99.2  
#   924 730 519 378 275 221 166 95 68  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1099
Cumulative Months of Follow-Up 46856
Number of Leads Active in Study 497
Information 7

Qualifying Complications

Conductor Fracture 1
Failure to Capture 2
Impedance Out of Range 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 at 102.0 mo  
% Survival 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1  
#   201 191 184 167 152 140 123 90 69  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 214
Cumulative Months of Follow-Up 17044
Number of Leads Active in Study 114
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 18
Conductor Fracture 1
Extra Cardiac Stimulation 2
Failure to Capture 47
Failure to Sense 1
Impedance Out of Range 3
Lead Dislodgement 58
Oversensing 2
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants105153
Estimated Active USA Implants59080
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution680876
Information

USA Returned Product Analysis

Conductor Fracture 7
Insulation Breach 32
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 10
Insulation Breach 33
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 April 14, 2016

www.medtronic.com/productperformance 426050