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 at 150.0 mo                
% Survival 99.4 99.3 99.2 99.2 99.2 99.2 99.2 99.2 99.2 98.6 98.6 98.6 98.6                
#   1003 832 688 587 443 309 243 196 166 146 131 79 63                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1157
Cumulative Months of Follow-Up 65561
Number of Leads Active in Study 326
Information 9

Qualifying Complications

Conductor Fracture 1
Failure to Capture 3
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 13 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 99.1                
#   214 205 198 183 167 158 148 135 125 113 103 76 52                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 227
Cumulative Months of Follow-Up 24411
Number of Leads Active in Study 99
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 25
Conductor Fracture 2
Extra Cardiac Stimulation 3
Failure to Capture 93
Failure to Sense 5
Impedance Out of Range 2
Lead Dislodgement 121
Oversensing 6
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants128034
Estimated Active USA Implants77325
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution847800
Information

USA Returned Product Analysis

Conductor Fracture 10
Insulation Breach 40
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 16
Insulation Breach 43
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 April 11, 2019

www.medtronic.com/productperformance 651050