4298 Attain Performa
Left-Heart Pacing
4298 Attain Performa
ALL
Information

Device Survival Probability

4298_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr    
% Survival 99.2 98.7 98.6 98.6 98.3 98.2 98.2 98.2    
#   1868 1580 1351 1043 751 516 300 85    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2244
Cumulative Months of Follow-Up 102599
Number of Leads Active in Study 886
Information 28

Qualifying Complications

Extra Cardiac Stimulation 5
Failure to Capture 5
Impedance Out of Range 0
Lead Dislodgement 15
Other 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 7
Conductor Fracture 1
Extra Cardiac Stimulation 228
Failure to Capture 151
Failure to Sense 1
Impedance Out of Range 42
Lead Dislodgement 248
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants115228
Estimated Active USA Implants88967
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution245123
Information

USA Returned Product Analysis

Conductor Fracture 7
Insulation Breach 0
Crimp/Weld/Bond 0
Other 27
Information

WW Returned Product Analysis

Conductor Fracture 10
Insulation Breach 0
Crimp/Weld/Bond 0
Other 31
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Double Curve
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Quadripolar
More
Serial Number Prefix QUA
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) Silicone (inner)
Pace/Sense Connector Style IS-4
High Voltage Connector n/a
Steroid Yes
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Data as of December 1, 2023

www.medtronic.com/productperformance 951051