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                
% Survival 99.4 99.3 99.2 99.2 99.2 99.2 99.2 99.2 99.2 98.6 98.6 97.8 97.8                
#   1009 840 697 590 458 334 254 207 168 146 137 108 59                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1168
Cumulative Months of Follow-Up 67456
Number of Leads Active in Study 314
Information 10

Qualifying Complications

Conductor Fracture 1
Failure to Capture 3
Impedance Out of Range 2
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 at 162.0 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              
#   214 205 198 183 167 158 148 135 126 114 106 93 61 54              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 227
Cumulative Months of Follow-Up 24976
Number of Leads Active in Study 98
Information 2

Qualifying Complications

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

US Acute Lead Observations

Cardiac Perforation 26
Conductor Fracture 2
Extra Cardiac Stimulation 3
Failure to Capture 104
Failure to Sense 6
Impedance Out of Range 3
Lead Dislodgement 140
Oversensing 7
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants132863
Estimated Active USA Implants80244
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution881190
Information

USA Returned Product Analysis

Conductor Fracture 10
Insulation Breach 41
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 16
Insulation Breach 44
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 November 8, 2019

www.medtronic.com/productperformance 726050