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 at 66.0 mo        
% Survival 99.3 98.9 98.8 98.8 98.8 98.8        
#   1743 1226 880 580 286 127        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2125
Cumulative Months of Follow-Up 68551
Number of Leads Active in Study 1243
Information 21

Qualifying Complications

Extra Cardiac Stimulation 4
Failure to Capture 1
Impedance Out of Range 0
Lead Dislodgement 13
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 201
Failure to Capture 115
Failure to Sense 1
Impedance Out of Range 34
Lead Dislodgement 206
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants96683
Estimated Active USA Implants74230
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution196021
Information

USA Returned Product Analysis

Conductor Fracture 6
Insulation Breach 0
Crimp/Weld/Bond 0
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 8
Insulation Breach 0
Crimp/Weld/Bond 0
Other 25
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 Bipolar
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 October 11, 2021

www.medtronic.com/productperformance 826050