5071 Screw-in
Epi/Myocardial Pacing
5071 Screw-in
ALL
Information

Device Survival Probability

5071_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr      
% Survival 95.2 91.8 90.0 90.0 88.4 86.5 85.1      
#   225 174 141 121 104 79 56      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 453
Cumulative Months of Follow-Up 15089
Number of Leads Active in Study 87
Information 33

Qualifying Complications

Conductor Fracture 4
Extra Cardiac Stimulation 1
Failure to Capture 20
Failure to Sense 2
Impedance Out of Range 1
Lead Dislodgement 2
Oversensing 2
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Extra Cardiac Stimulation 6
Failure to Capture 94
Failure to Sense 3
Impedance Out of Range 11
Lead Dislodgement 2
Oversensing 1
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1992-12-03
CE Approval Date1993-01-01
Registered USA Implants55730
Estimated Active USA Implants12165
US Market Release1992-12-03
CE Approval Date1993-01-01
Estimated WW Distribution110438
Information

USA Returned Product Analysis

Conductor Fracture 29
Insulation Breach 2
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 30
Insulation Breach 3
Crimp/Weld/Bond 1
Other 5
Information

Product Characteristics

Lead Type Epi/Myocardial
Type and/or Fixation Fixed Screw
Lead Function Pacing/Sensing
Lead Placement Myocardial
Lead Tip Location Right Ventricle
Pace/Sense Polarity Unipolar
More
Serial Number Prefix LAQ
Lead Body Diameter 6.6 FR
Insulation Silicon
Pace/Sense Connector Style IS-1 UNI
High Voltage Connector n/a
Steroid None
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Data as of October 11, 2021

www.medtronic.com/productperformance 826050