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 8 yr at 102.0 mo  
% Survival 99.2 99.0 98.9 98.7 98.5 98.5 98.5 98.0 98.0  
#   1168 980 811 678 550 369 222 116 71  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1388
Cumulative Months of Follow-Up 67043
Number of Leads Active in Study 365
Information 17

Qualifying Complications

Extra Cardiac Stimulation 3
Failure to Capture 1
Failure to Sense 1
Lead Dislodgement 12
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 12
Conductor Fracture 2
Extra Cardiac Stimulation 148
Failure to Capture 111
Impedance Out of Range 40
Lead Dislodgement 96
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants82691
Estimated Active USA Implants66788
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution181722
Information

USA Returned Product Analysis

Conductor Fracture 7
Insulation Breach 0
Crimp/Weld/Bond 0
Other 15
Information

WW Returned Product Analysis

Conductor Fracture 12
Insulation Breach 1
Crimp/Weld/Bond 0
Other 21
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 May 24, 2025

www.medtronic.com/productperformance 1051050