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    
% Survival 99.2 99.0 98.8 98.5 98.5 98.0 98.0 97.3    
#   593 489 405 318 251 202 140 66    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 772
Cumulative Months of Follow-Up 34626
Number of Leads Active in Study 354
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 at 102.0 mo  
% Survival 99.3 99.0 99.0 98.9 98.7 98.4 97.8 97.0 96.3  
#   896 739 628 514 418 349 247 122 74  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1100
Cumulative Months of Follow-Up 54197
Number of Leads Active in Study 483
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
HIS PLACEMENT
Information

Device Survival Probability

3830_HIS_SURV
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    1 yr 2 yr 3 yr              
% Survival 98.0 98.0 98.0              
#   133 91 56              

Product Surveillance Registry Results

Number of Leads Enrolled in Study
Cumulative Months of Follow-Up
Number of Leads Active in Study
Information

Qualifying Complications

Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 11
Conductor Fracture 2
Extra Cardiac Stimulation 4
Failure to Capture 145
Failure to Sense 7
Impedance Out of Range 1
Insulation Breach 1
Lead Dislodgement 190
Oversensing 35
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants49472
Estimated Active USA Implants39220
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution124126
Information

USA Returned Product Analysis

Conductor Fracture 23
Insulation Breach 36
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 30
Insulation Breach 41
Crimp/Weld/Bond 0
Other 9
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 11, 2019

www.medtronic.com/productperformance 651050