4558M Screw-In
Pacing
4558M Screw-In
ALL
Information

Device Survival Probability

4558M_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr  
% Survival 99.1 99.1 99.1 99.1 99.1 97.1 95.9 95.9 91.1  
#   278 225 180 140 115 88 80 64 53  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 540
Cumulative Months of Follow-Up 18589
Number of Leads Active in Study 5
Information 12

Qualifying Complications

Electrical Abandonment 1
Failure to Capture 3
Failure to Sense 2
Impedance Out of Range 2
Insulation (not further defined) 2
Oversensing 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Extra Cardiac Stimulation 1
Failure to Capture 2
Failure to Sense 1
Impedance Out of Range 1
Lead Dislodgement 2
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1994-11-14
CE Approval Date
Registered USA Implants19566
Estimated Active USA Implants3640
US Market Release1994-11-14
CE Approval Date
Estimated WW Distribution20937
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 23
Crimp/Weld/Bond 0
Other 20
Information

WW Returned Product Analysis

Conductor Fracture 1
Insulation Breach 23
Crimp/Weld/Bond 0
Other 65
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Active Screw In
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium - J
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LDC
Lead Body Diameter 7.5 FR
Insulation Polyurethane
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid None
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Data as of August 3, 2014

www.medtronic.com/productperformance 326050