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 8 yr 9 yr  
% Survival 99.1 98.8 98.5 98.3 98.3 97.4 97.4 96.9 96.9  
#   654 535 434 332 278 212 170 123 56  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1008
Cumulative Months of Follow-Up 38848
Number of Leads Active in Study 542
Information 13

Qualifying Complications

Failure to Capture 6
Impedance Out of Range 1
Lead Dislodgement 5
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 9 yr at 114.0 mo
% Survival 99.4 99.1 99.1 99.0 98.8 98.5 97.9 97.3 96.9 96.9
#   956 787 656 524 446 363 297 228 101 59

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1209
Cumulative Months of Follow-Up 59755
Number of Leads Active in Study 538
Information 18

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
Insulation (not further defined) 1
Lead Dislodgement 4
Other 0
HIS PLACEMENT
Information

Device Survival Probability

3830_HIS_SURV
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    1 yr 2 yr 3 yr at 42.0 mo            
% Survival 98.2 96.6 96.6 93.8            
#   240 131 78 55            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 693
Cumulative Months of Follow-Up 8914
Number of Leads Active in Study 585
Information 13

Qualifying Complications

Failure to Capture 11
Impedance Out of Range 0
Lead Dislodgement 1
Oversensing 1
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 24
Conductor Fracture 2
Extra Cardiac Stimulation 5
Failure to Capture 219
Failure to Sense 17
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 261
Oversensing 50
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants64960
Estimated Active USA Implants52639
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution177743
Information

USA Returned Product Analysis

Conductor Fracture 27
Insulation Breach 43
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 34
Insulation Breach 48
Crimp/Weld/Bond 0
Other 10
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 10, 2020

www.medtronic.com/productperformance 751050