3830 SelectSecure
Pacing
3830 SelectSecure
LEFT BUNDLE PLACEMENT
Information

Device Survival Probability

3830_LBBA_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr          
% Survival 99.5 99.2 98.8 98.8 98.8          
#   1874 1046 383 161 53          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2216
Cumulative Months of Follow-Up 53111
Number of Leads Active in Study 1675
Information 16

Qualifying Complications

Conductor Fracture 1
Failure to Capture 8
Lead Dislodgement 7
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 9 yr 10 yr 11 yr 12 yr 13 yr at 162.0 mo              
% Survival 99.5 99.1 98.8 98.8 98.6 98.0 98.0 97.6 97.6 97.6 97.6 97.6 97.6 97.6              
#   2295 2013 1468 917 608 392 271 217 170 127 113 93 61 52              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2609
Cumulative Months of Follow-Up 119486
Number of Leads Active in Study 1278
Information 32

Qualifying Complications

Failure to Capture 18
Impedance Out of Range 1
Lead Dislodgement 11
Other 2
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 10 yr 11 yr 12 yr 13 yr 14 yr at 174.0 mo            
% Survival 99.6 99.3 99.3 99.2 99.1 98.9 98.5 98.0 97.7 96.9 96.9 96.9 96.9 96.9 96.9            
#   1601 1345 1080 832 663 528 414 345 283 226 199 160 99 67 51            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1847
Cumulative Months of Follow-Up 104520
Number of Leads Active in Study 533
Information 21

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 3
Extra Cardiac Stimulation 1
Failure to Capture 4
Failure to Sense 2
Impedance Out of Range 2
Insulation (not further defined) 1
Lead Dislodgement 6
Oversensing 1
HIS BUNDLE PLACEMENT
Information

Device Survival Probability

3830_HIS_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr    
% Survival 98.1 97.4 97.1 96.3 95.7 94.9 94.9 92.1    
#   1305 1109 895 670 420 215 101 53    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1500
Cumulative Months of Follow-Up 65620
Number of Leads Active in Study 723
Information 53

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 38
Failure to Sense 3
Lead Dislodgement 6
Oversensing 2
Other 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 130
Conductor Fracture 7
Extra Cardiac Stimulation 12
Failure to Capture 955
Failure to Sense 157
Impedance Out of Range 119
Insulation Breach 2
Lead Dislodgement 1223
Oversensing 197
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants388310
Estimated Active USA Implants344205
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution1065088
Information

USA Returned Product Analysis

Conductor Fracture 50
Insulation Breach 161
Crimp/Weld/Bond 0
Other 31
Information

WW Returned Product Analysis

Conductor Fracture 62
Insulation Breach 179
Crimp/Weld/Bond 0
Other 34
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Fixed Screw
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium, Ventricle, Bundle of His, or Left Bundle Branch Area
Pace/Sense Polarity Bipolar
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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 June 8, 2026

www.medtronic.com/productperformance 22521