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 13 yr 14 yr 15 yr at 186.0 mo          
% Survival 99.4 99.3 99.2 99.2 99.2 99.2 99.2 99.2 99.2 98.7 98.7 98.0 98.0 97.2 97.2 97.2          
#   1017 859 707 596 467 380 323 269 218 173 151 138 119 103 66 55          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1188
Cumulative Months of Follow-Up 74402
Number of Leads Active in Study 263
Information 11

Qualifying Complications

Conductor Fracture 1
Failure to Capture 3
Impedance Out of Range 2
Insulation (not further defined) 2
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 14 yr 15 yr at 186.0 mo          
% 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 99.1 99.1 99.1          
#   214 205 198 183 167 158 148 136 126 117 109 103 94 84 57 52          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 227
Cumulative Months of Follow-Up 27251
Number of Leads Active in Study 90
Information 2

Qualifying Complications

Failure to Capture 0
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 1
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 29
Conductor Fracture 2
Extra Cardiac Stimulation 3
Failure to Capture 148
Failure to Sense 9
Impedance Out of Range 4
Lead Dislodgement 182
Oversensing 7
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants147071
Estimated Active USA Implants67502
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution991159
Information

USA Returned Product Analysis

Conductor Fracture 13
Insulation Breach 50
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 20
Insulation Breach 53
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 December 16, 2021

www.medtronic.com/productperformance 851050