3830 SelectSecure
Pacing
3830 SelectSecure
VENTRICULAR PLACEMENT
Information

Device Survival Probability

3830_VEN_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 102.0 mo  
% Survival 99.2 99.0 98.8 98.6 98.6 98.1 98.1 97.5 97.5  
#   622 519 413 327 272 207 162 92 58  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 888
Cumulative Months of Follow-Up 36818
Number of Leads Active in Study 454
Information 10

Qualifying Complications

Failure to Capture 4
Impedance Out of Range 1
Lead Dislodgement 4
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability

3830_ATR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr  
% Survival 99.3 99.1 99.1 98.9 98.7 98.5 97.9 97.2 96.7  
#   928 774 634 520 435 352 284 179 64  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1163
Cumulative Months of Follow-Up 57220
Number of Leads Active in Study 517
Information 18

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Extra Cardiac Stimulation 1
Failure to Capture 4
Failure to Sense 3
Impedance Out of Range 2
Insulation (not further defined) 1
Lead Dislodgement 4
Other 0
HIS PLACEMENT
Information

Device Survival Probability

3830_HIS_SURV
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    1 yr 2 yr 3 yr              
% Survival 98.2 97.6 97.6              
#   178 108 68              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 537
Cumulative Months of Follow-Up 6799
Number of Leads Active in Study 464
Information 8

Qualifying Complications

Failure to Capture 6
Impedance Out of Range 0
Lead Dislodgement 1
Oversensing 1
Other 0
Information

US Acute Lead Observations

Cardiac Perforation 15
Conductor Fracture 2
Extra Cardiac Stimulation 5
Failure to Capture 187
Failure to Sense 10
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 218
Oversensing 47
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants58098
Estimated Active USA Implants46768
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution154726
Information

USA Returned Product Analysis

Conductor Fracture 24
Insulation Breach 41
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 31
Insulation Breach 46
Crimp/Weld/Bond 0
Other 9
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Fixed Screw
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium or Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LFF
Lead Body Diameter 4.1 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