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 at 114.0 mo
% Survival 99.2 98.9 98.7 98.4 98.4 97.6 97.6 97.1 97.1 97.1
#   777 565 476 353 295 236 188 158 117 83

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1245
Cumulative Months of Follow-Up 44540
Number of Leads Active in Study 719
Information 14

Qualifying Complications

Failure to Capture 7
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 at 54.0 mo          
% Survival 97.9 96.2 95.6 93.7 92.2          
#   488 211 109 73 50          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1012
Cumulative Months of Follow-Up 15103
Number of Leads Active in Study 831
Information 25

Qualifying Complications

Failure to Capture 19
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 2
Oversensing 1
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                    
% Survival 99.4 99.2 99.2 99.0 98.8 98.6 98.1 97.4 97.1 95.7 95.7                    
#   991 796 684 544 460 391 328 285 211 100 55                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1346
Cumulative Months of Follow-Up 65274
Number of Leads Active in Study 608
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 32
Conductor Fracture 3
Extra Cardiac Stimulation 8
Failure to Capture 309
Failure to Sense 28
Impedance Out of Range 8
Insulation Breach 1
Lead Dislodgement 360
Oversensing 75
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants95696
Estimated Active USA Implants73404
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution287110
Information

USA Returned Product Analysis

Conductor Fracture 29
Insulation Breach 52
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 36
Insulation Breach 57
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 October 11, 2021

www.medtronic.com/productperformance 826050