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 16 yr 17 yr        
% Survival 99.4 99.3 99.2 99.2 99.2 99.2 99.2 99.2 99.2 98.8 98.8 97.5 97.5 96.7 96.7 96.7 96.7        
#   1029 878 737 624 481 393 337 294 252 203 171 151 121 117 111 84 52        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1193
Cumulative Months of Follow-Up 79817
Number of Leads Active in Study 167
Information 12

Qualifying Complications

Conductor Fracture 1
Failure to Capture 4
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 16 yr 17 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 99.1 99.1 99.1 99.1        
#   214 205 198 183 167 158 148 136 126 117 110 107 98 94 88 73 51        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 227
Cumulative Months of Follow-Up 29196
Number of Leads Active in Study 61
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 33
Conductor Fracture 2
Extra Cardiac Stimulation 3
Failure to Capture 183
Failure to Sense 15
Impedance Out of Range 6
Lead Dislodgement 204
Oversensing 8
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants152971
Estimated Active USA Implants72703
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution1070831
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 57
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 20
Insulation Breach 61
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 1, 2023

www.medtronic.com/productperformance 951051