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 at 54.0 mo          
% Survival 99.3 99.0 98.9 98.9 98.9          
#   1404 997 643 295 145          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2083
Cumulative Months of Follow-Up 52042
Number of Leads Active in Study 1419
Information 16

Qualifying Complications

Extra Cardiac Stimulation 4
Failure to Capture 0
Impedance Out of Range 0
Lead Dislodgement 11
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 5
Conductor Fracture 1
Extra Cardiac Stimulation 178
Failure to Capture 96
Failure to Sense 1
Impedance Out of Range 24
Lead Dislodgement 162
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants80775
Estimated Active USA Implants74475
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution158660
Information

USA Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 16
Information

WW Returned Product Analysis

Conductor Fracture 6
Insulation Breach 0
Crimp/Weld/Bond 0
Other 19
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 April 10, 2020

www.medtronic.com/productperformance 751050