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 at 114.0 mo
% Survival 99.2 98.7 98.5 98.3 98.3 97.5 97.5 96.9 96.9 96.9
#   684 548 461 346 288 231 183 151 98 69

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1118
Cumulative Months of Follow-Up 41812
Number of Leads Active in Study 607
Information 14

Qualifying Complications

Failure to Capture 7
Impedance Out of Range 1
Lead Dislodgement 5
Other 1
HIS BUNDLE PLACEMENT
Information

Device Survival Probability

3830_HIS_SURV
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    1 yr 2 yr 3 yr 4 yr            
% Survival 98.2 96.6 96.6 94.4            
#   366 169 98 61            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 841
Cumulative Months of Follow-Up 12014
Number of Leads Active in Study 695
Information 18

Qualifying Complications

Failure to Capture 14
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 2
Oversensing 1
Other 0
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 10 yr at 126.0 mo
% Survival 99.4 99.2 99.2 99.0 98.8 98.6 98.0 97.4 97.0 95.2  
#   961 781 673 540 458 386 324 279 178 74 59

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1266
Cumulative Months of Follow-Up 63202
Number of Leads Active in Study 551
Information 19

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 3
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
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 26
Conductor Fracture 2
Extra Cardiac Stimulation 6
Failure to Capture 247
Failure to Sense 20
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 288
Oversensing 56
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2005-08-03
CE Approval Date2003-01-31
Registered USA Implants73220
Estimated Active USA Implants59861
US Market Release2005-08-03
CE Approval Date2003-01-31
Estimated WW Distribution205772
Information

USA Returned Product Analysis

Conductor Fracture 27
Insulation Breach 45
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 34
Insulation Breach 50
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 or Bundle of His
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 October 29, 2020

www.medtronic.com/productperformance 776050