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          
% Survival 95.4 92.2 89.6 89.6 88.1          
#   193 141 103 72 52          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 408
Cumulative Months of Follow-Up 10188
Number of Leads Active in Study 105
Information 25

Qualifying Complications

Conductor Fracture 1
Failure to Capture 18
Failure to Sense 2
Impedance Out of Range 1
Lead Dislodgement 1
Oversensing 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Extra Cardiac Stimulation 6
Failure to Capture 55
Failure to Sense 3
Impedance Out of Range 6
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1992-12-03
CE Approval Date1993-01-01
Registered USA Implants51065
Estimated Active USA Implants15771
US Market Release1992-12-03
CE Approval Date1993-01-01
Estimated WW Distribution96911
Information

USA Returned Product Analysis

Conductor Fracture 20
Insulation Breach 2
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 21
Insulation Breach 3
Crimp/Weld/Bond 1
Other 9
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 February 3, 2017

www.medtronic.com/productperformance 476050