3830 SelectSecure
Pacing
3830 SelectSecure
LEFT BUNDLE PLACEMENT
Information

Device Survival Probability

3830_LBBA_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr            
% Survival 99.6 99.3 98.7 98.7            
#   1726 661 268 82            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2206
Cumulative Months of Follow-Up 43475
Number of Leads Active in Study 1734
Information 13

Qualifying Complications

Conductor Fracture 1
Failure to Capture 7
Lead Dislodgement 5
VENTRICULAR PLACEMENT
Information

Device Survival Probability

3830_VEN_SURV
Loading...











    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 99.2 98.9 98.8 98.7 98.1 98.1 97.7 97.7 97.7 97.7 97.7 97.7 97.7              
#   2275 1901 1261 788 533 341 258 208 166 125 113 92 59 50              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2601
Cumulative Months of Follow-Up 111318
Number of Leads Active in Study 1374
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
Loading...











    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              
#   1591 1297 1023 797 630 503 400 338 277 223 198 158 98 58              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1846
Cumulative Months of Follow-Up 101289
Number of Leads Active in Study 592
Information 21

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 5
Oversensing 1
HIS BUNDLE PLACEMENT
Information

Device Survival Probability

3830_HIS_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 90.0 mo    
% Survival 98.3 97.5 97.2 96.6 96.0 95.2 95.2 93.8    
#   1299 1066 851 600 371 171 82 58    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1504
Cumulative Months of Follow-Up 61964
Number of Leads Active in Study 774
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 113
Conductor Fracture 6
Extra Cardiac Stimulation 13
Failure to Capture 839
Failure to Sense 136
Impedance Out of Range 95
Insulation Breach 2
Lead Dislodgement 1102
Oversensing 173
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants346261
Estimated Active USA Implants305755
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution941988
Information

USA Returned Product Analysis

Conductor Fracture 49
Insulation Breach 140
Crimp/Weld/Bond 0
Other 28
Information

WW Returned Product Analysis

Conductor Fracture 60
Insulation Breach 154
Crimp/Weld/Bond 0
Other 31
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
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
Hide this content

Data as of December 1, 2025

www.medtronic.com/productperformance 22021