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 at 198.0 mo        
% Survival 99.4 99.3 99.2 99.2 99.2 99.2 99.2 99.2 99.2 98.8 98.8 98.1 98.1 97.3 97.3 97.3 97.3        
#   1029 876 730 616 476 390 330 291 243 190 161 141 121 116 108 68 56        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1191
Cumulative Months of Follow-Up 78251
Number of Leads Active in Study 195
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 16 yr at 198.0 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 99.1        
#   214 205 198 183 167 158 148 136 126 117 110 107 98 92 88 62 54        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 227
Cumulative Months of Follow-Up 28700
Number of Leads Active in Study 68
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 32
Conductor Fracture 2
Extra Cardiac Stimulation 3
Failure to Capture 171
Failure to Sense 12
Impedance Out of Range 6
Lead Dislodgement 201
Oversensing 8
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants150312
Estimated Active USA Implants70608
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution1051557
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 55
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 20
Insulation Breach 59
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 May 10, 2023

www.medtronic.com/productperformance 926050