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    
% Survival 99.0 98.8 98.6 98.4 98.4 97.9 97.9 97.0    
#   598 492 410 321 252 197 119 53    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 845
Cumulative Months of Follow-Up 34491
Number of Leads Active in Study 432
Information 11

Qualifying Complications

Failure to Capture 4
Impedance Out of Range 1
Lead Dislodgement 5
Other 1
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 at 102.0 mo  
% Survival 99.3 99.0 99.0 98.9 98.7 98.4 97.7 96.7 95.7  
#   877 715 622 497 409 340 202 84 56  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1065
Cumulative Months of Follow-Up 51841
Number of Leads Active in Study 475
Information 18

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
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
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 10
Conductor Fracture 2
Extra Cardiac Stimulation 4
Failure to Capture 120
Failure to Sense 6
Impedance Out of Range 1
Insulation Breach 1
Lead Dislodgement 151
Oversensing 24
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants43438
Estimated Active USA Implants33723
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution101925
Information

USA Returned Product Analysis

Conductor Fracture 22
Insulation Breach 35
Crimp/Weld/Bond 0
Other 6
Information

WW Returned Product Analysis

Conductor Fracture 28
Insulation Breach 40
Crimp/Weld/Bond 0
Other 7
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
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 12, 2018

www.medtronic.com/productperformance 626050