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 11 yr 12 yr at 150.0 mo                
% Survival 99.4 99.1 98.7 98.6 98.3 97.6 97.6 97.2 97.2 97.2 97.2 97.2 97.2                
#   1534 1002 717 455 350 272 221 186 154 116 100 74 50                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2524
Cumulative Months of Follow-Up 73178
Number of Leads Active in Study 1695
Information 22

Qualifying Complications

Failure to Capture 11
Impedance Out of Range 2
Lead Dislodgement 8
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 6 yr at 78.0 mo      
% Survival 98.3 97.4 97.0 95.8 94.8 93.6 93.6      
#   1092 773 479 240 106 64 51      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1435
Cumulative Months of Follow-Up 40363
Number of Leads Active in Study 953
Information 40

Qualifying Complications

Failure to Capture 30
Failure to Sense 3
Impedance Out of Range 0
Lead Dislodgement 4
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 12 yr 13 yr                
% Survival 99.6 99.3 99.3 99.2 99.0 98.8 98.3 97.7 97.4 96.6 96.6 96.6 96.6                
#   1308 1032 833 649 517 436 357 313 263 213 186 126 59                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1774
Cumulative Months of Follow-Up 84591
Number of Leads Active in Study 756
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 62
Conductor Fracture 5
Extra Cardiac Stimulation 10
Failure to Capture 530
Failure to Sense 74
Impedance Out of Range 39
Insulation Breach 2
Lead Dislodgement 635
Oversensing 106
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants184124
Estimated Active USA Implants155562
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution529839
Information

USA Returned Product Analysis

Conductor Fracture 36
Insulation Breach 82
Crimp/Weld/Bond 0
Other 13
Information

WW Returned Product Analysis

Conductor Fracture 45
Insulation Breach 92
Crimp/Weld/Bond 0
Other 15
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 1, 2023

www.medtronic.com/productperformance 951051