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 at 90.0 mo    
% Survival 99.1 98.9 98.7 98.4 98.4 97.9 97.9 96.8    
#   560 476 401 305 247 180 94 52    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 761
Cumulative Months of Follow-Up 32259
Number of Leads Active in Study 382
Information 10

Qualifying Complications

Failure to Capture 4
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 8 yr    
% Survival 99.3 99.0 99.0 98.8 98.6 98.3 98.0 96.6    
#   838 705 609 483 403 305 150 63    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1016
Cumulative Months of Follow-Up 48914
Number of Leads Active in Study 465
Information 17

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
Lead Dislodgement 4
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 9
Conductor Fracture 2
Extra Cardiac Stimulation 2
Failure to Capture 79
Failure to Sense 4
Insulation Breach 1
Lead Dislodgement 101
Oversensing 13
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants37163
Estimated Active USA Implants27949
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution82661
Information

USA Returned Product Analysis

Conductor Fracture 19
Insulation Breach 34
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 25
Insulation Breach 38
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 January 31, 2018

www.medtronic.com/productperformance 601051