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 at 78.0 mo      
% Survival 99.2 99.0 98.7 98.7 98.7 97.7 97.7      
#   507 439 358 272 173 76 58      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 629
Cumulative Months of Follow-Up 26910
Number of Leads Active in Study 309
Information 8

Qualifying Complications

Failure to Capture 2
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      
% Survival 99.2 98.9 98.9 98.7 98.5 98.5 98.5      
#   790 663 565 450 280 116 55      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 927
Cumulative Months of Follow-Up 41345
Number of Leads Active in Study 454
Information 13

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 3
Failure to Sense 2
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 8
Conductor Fracture 2
Failure to Capture 29
Failure to Sense 2
Insulation Breach 1
Lead Dislodgement 50
Oversensing 5
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants26630
Estimated Active USA Implants18604
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution57717
Information

USA Returned Product Analysis

Conductor Fracture 12
Insulation Breach 26
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 17
Insulation Breach 30
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 August 3, 2016

www.medtronic.com/productperformance 451050