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 9 yr 10 yr at 126.0 mo                    
% Survival 99.2 98.9 98.5 98.3 98.3 97.5 97.5 97.0 97.0 97.0 97.0                    
#   920 623 496 368 300 245 205 162 132 85 54                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1454
Cumulative Months of Follow-Up 49094
Number of Leads Active in Study 877
Information 16

Qualifying Complications

Failure to Capture 9
Impedance Out of Range 1
Lead Dislodgement 5
Other 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          
% Survival 97.9 96.5 96.1 94.5 91.6          
#   671 300 139 84 50          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1143
Cumulative Months of Follow-Up 20012
Number of Leads Active in Study 903
Information 31

Qualifying Complications

Failure to Capture 23
Failure to Sense 2
Impedance Out of Range 0
Lead Dislodgement 2
Oversensing 1
Other 3
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 at 138.0 mo                  
% Survival 99.5 99.2 99.2 99.1 98.9 98.7 98.1 97.5 97.2 96.2 96.2 96.2                  
#   1070 847 703 566 463 398 338 287 237 160 71 53                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1418
Cumulative Months of Follow-Up 69373
Number of Leads Active in Study 640
Information 19

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
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 34
Conductor Fracture 3
Extra Cardiac Stimulation 8
Failure to Capture 317
Failure to Sense 28
Impedance Out of Range 8
Insulation Breach 1
Lead Dislodgement 368
Oversensing 78
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants99929
Estimated Active USA Implants77293
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution302158
Information

USA Returned Product Analysis

Conductor Fracture 29
Insulation Breach 53
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 36
Insulation Breach 59
Crimp/Weld/Bond 0
Other 10
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 or Bundle of His
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 December 16, 2021

www.medtronic.com/productperformance 851050