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

Device Survival Probability


5071_SURV
    1 yr 2 yr 3 yr at 42 mo            
% Survival 96.2 92.4 89.5 89.5            
#   124 86 58 55            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 331
Cumulative Months of Follow-Up 6671
Number of Leads Active in Study 84
Information 15

Qualifying Complications

Failure to Capture 12
Impedance Out of Range 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 3
Failure to Capture 34
Failure to Sense 2
Impedance Out of Range 2
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1992-12-03
CE Approval Date1993-01-01
Registered USA Implants46017
Estimated Active USA Implants15556
US Market Release1992-12-03
CE Approval Date1993-01-01
Estimated WW Distribution83683
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 2
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 15
Insulation Breach 3
Crimp/Weld/Bond 1
Other 9
Information

Product Characteristics

Lead Type Epi/Myocardial
Type and/or Fixation Fixed Screw In
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 January 31, 2014

www.medtronic.com/productperformance 301050