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 9 yr  
% Survival 99.1 98.7 98.6 98.6 98.4 98.2 98.2 98.2 98.2  
#   1893 1612 1372 1155 887 654 450 249 77  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2271
Cumulative Months of Follow-Up 112894
Number of Leads Active in Study 617
Information 29

Qualifying Complications

Extra Cardiac Stimulation 5
Failure to Capture 5
Lead Dislodgement 16
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 244
Failure to Capture 172
Failure to Sense 1
Impedance Out of Range 46
Lead Dislodgement 265
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants123082
Estimated Active USA Implants94914
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution268358
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 November 20, 2024

www.medtronic.com/productperformance 1026050