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 99.1 99.1 99.1 99.1 99.1 97.3 97.3      
#   449 377 281 129 77 52 50      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 560
Cumulative Months of Follow-Up 20713
Number of Leads Active in Study 319
Information 6

Qualifying Complications

Failure to Capture 1
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 99.1 99.0 99.0 99.0 99.0 99.0 99.0      
#   719 607 462 199 100 57 51      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 856
Cumulative Months of Follow-Up 31736
Number of Leads Active in Study 492
Information 10

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 2
Failure to Sense 1
Impedance Out of Range 2
Lead Dislodgement 2
Other 0
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 7
Conductor Fracture 1
Failure to Capture 22
Failure to Sense 1
Insulation Breach 1
Lead Dislodgement 36
Oversensing 3
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants23886
Estimated Active USA Implants17729
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution47125
Information

USA Returned Product Analysis

Conductor Fracture 10
Insulation Breach 22
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 14
Insulation Breach 26
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 February 9, 2015

www.medtronic.com/productperformance 351052