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 99.2 98.9 98.9 98.9 97.5 97.5      
#   494 416 347 245 118 59 52      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 596
Cumulative Months of Follow-Up 24803
Number of Leads Active in Study 295
Information 7

Qualifying Complications

Failure to Capture 2
Impedance Out of Range 1
Lead Dislodgement 3
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 at 78.0 mo      
% Survival 99.2 99.0 99.0 98.9 98.6 98.6 98.6      
#   775 644 555 403 196 85 62      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 888
Cumulative Months of Follow-Up 38360
Number of Leads Active in Study 435
Information 12

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 2
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 26
Failure to Sense 2
Insulation Breach 1
Lead Dislodgement 43
Oversensing 5
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants26046
Estimated Active USA Implants18180
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution55674
Information

USA Returned Product Analysis

Conductor Fracture 11
Insulation Breach 24
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 15
Insulation Breach 28
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 April 14, 2016

www.medtronic.com/productperformance 426050