3830 SelectSecure
Pacing
3830 SelectSecure
VENTRICULAR PLACEMENT
Information

Device Survival Probability


3830_VEN_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr        
% Survival 99.3 99.3 99.3 99.3 99.3 97.3        
#   411 296 157 92 63 50        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 537
Cumulative Months of Follow-Up 16381
Number of Leads Active in Study 329
Information 5

Qualifying Complications

Failure to Capture 1
Impedance Out of Range 1
Lead Dislodgement 2
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability


3830_ATR_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr at 66 mo        
% Survival 99.1 99.1 99.1 99.1 99.1 99.1        
#   672 490 250 118 68 56        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 804
Cumulative Months of Follow-Up 24884
Number of Leads Active in Study 500
Information 7

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 1
Failure to Sense 1
Lead Dislodgement 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 6
Conductor Fracture 1
Failure to Capture 15
Failure to Sense 1
Insulation Breach 1
Lead Dislodgement 32
Oversensing 3
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants22216
Estimated Active USA Implants16715
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution42687
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 15
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 8
Insulation Breach 19
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, 2014

www.medtronic.com/productperformance 301050