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 at 42.0 mo            
% Survival 99.5 99.0 98.1 98.1            
#   1245 454 178 95            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2189
Cumulative Months of Follow-Up 32041
Number of Leads Active in Study 1817
Information 13

Qualifying Complications

Conductor Fracture 1
Failure to Capture 7
Lead Dislodgement 5
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                
% Survival 99.5 99.1 98.8 98.7 98.5 97.9 97.9 97.5 97.5 97.5 97.5 97.5 97.5                
#   2220 1627 1042 681 447 316 249 199 163 125 109 91 55                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2600
Cumulative Months of Follow-Up 101289
Number of Leads Active in Study 1460
Information 27

Qualifying Complications

Failure to Capture 14
Impedance Out of Range 2
Lead Dislodgement 9
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              
% Survival 99.6 99.3 99.3 99.2 99.1 98.9 98.4 97.9 97.6 96.8 96.8 96.8 96.8 96.8              
#   1549 1213 965 750 592 474 387 326 273 223 196 158 92 51              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1843
Cumulative Months of Follow-Up 96807
Number of Leads Active in Study 626
Information 20

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 3
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
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      
% Survival 98.3 97.5 97.1 96.4 95.8 94.6 94.6      
#   1269 1022 768 507 277 124 66      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1505
Cumulative Months of Follow-Up 56792
Number of Leads Active in Study 816
Information 48

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 34
Failure to Sense 3
Lead Dislodgement 6
Oversensing 1
Other 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 95
Conductor Fracture 6
Extra Cardiac Stimulation 12
Failure to Capture 741
Failure to Sense 117
Impedance Out of Range 72
Insulation Breach 2
Lead Dislodgement 962
Oversensing 150
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants299222
Estimated Active USA Implants262255
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution823488
Information

USA Returned Product Analysis

Conductor Fracture 43
Insulation Breach 121
Crimp/Weld/Bond 0
Other 25
Information

WW Returned Product Analysis

Conductor Fracture 52
Insulation Breach 133
Crimp/Weld/Bond 0
Other 28
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 May 24, 2025

www.medtronic.com/productperformance 1051050