4598 Attain Performa S
Left-Heart Pacing
4598 Attain Performa S
ALL
Information

Device Survival Probability

4598_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 90.0 mo    
% Survival 99.2 99.0 98.9 98.6 98.5 98.5 98.5 97.0    
#   1126 950 782 602 383 220 105 55    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1364
Cumulative Months of Follow-Up 57890
Number of Leads Active in Study 560
Information 17

Qualifying Complications

Extra Cardiac Stimulation 3
Failure to Capture 1
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 12
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 11
Conductor Fracture 2
Extra Cardiac Stimulation 130
Failure to Capture 92
Impedance Out of Range 33
Lead Dislodgement 82
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants73022
Estimated Active USA Implants59049
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution156466
Information

USA Returned Product Analysis

Conductor Fracture 6
Insulation Breach 0
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 11
Insulation Breach 0
Crimp/Weld/Bond 0
Other 18
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation S-shape
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Quadripolar
More
Serial Number Prefix QUC
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) SI-polyimide (SI-PI)(inner)
Pace/Sense Connector Style IS4-LLLL
High Voltage Connector n/a
Steroid Yes
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Data as of December 1, 2023

www.medtronic.com/productperformance 951051