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      
% Survival 99.3 99.1 98.8 98.5 98.5 98.0 98.0      
#   536 464 388 293 239 144 72      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 713
Cumulative Months of Follow-Up 30338
Number of Leads Active in Study 350
Information 9

Qualifying Complications

Failure to Capture 3
Impedance Out of Range 1
Lead Dislodgement 4
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 at 90.0 mo    
% Survival 99.2 99.0 99.0 98.8 98.6 98.2 97.8 97.0    
#   811 695 597 470 390 242 106 64    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 992
Cumulative Months of Follow-Up 46492
Number of Leads Active in Study 462
Information 15

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Extra Cardiac Stimulation 1
Failure to Capture 3
Failure to Sense 3
Impedance Out of Range 2
Lead Dislodgement 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 9
Conductor Fracture 2
Failure to Capture 49
Failure to Sense 3
Insulation Breach 1
Lead Dislodgement 73
Oversensing 9
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants32791
Estimated Active USA Implants23884
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution71828
Information

USA Returned Product Analysis

Conductor Fracture 15
Insulation Breach 30
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 21
Insulation Breach 34
Crimp/Weld/Bond 0
Other 4
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 July 31, 2017

www.medtronic.com/productperformance 501050