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

Device Survival Probability

4298_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr        
% Survival 99.3 98.9 98.8 98.8 98.6 98.6        
#   1795 1400 984 687 419 122        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2149
Cumulative Months of Follow-Up 76884
Number of Leads Active in Study 1167
Information 22

Qualifying Complications

Extra Cardiac Stimulation 4
Failure to Capture 2
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 204
Failure to Capture 118
Failure to Sense 1
Impedance Out of Range 35
Lead Dislodgement 208
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants98276
Estimated Active USA Implants75521
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution200255
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
Hide this content

Data as of December 16, 2021

www.medtronic.com/productperformance 851050