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 at 42.0 mo            
% Survival 99.2 98.8 98.6 98.6            
#   1152 740 336 163            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1760
Cumulative Months of Follow-Up 36241
Number of Leads Active in Study 1298
Information 16

Qualifying Complications

Extra Cardiac Stimulation 4
Lead Dislodgement 11
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 4
Conductor Fracture 1
Extra Cardiac Stimulation 154
Failure to Capture 84
Failure to Sense 1
Impedance Out of Range 18
Lead Dislodgement 122
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants67426
Estimated Active USA Implants63440
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution132360
Information

USA Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 13
Information

WW Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 15
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 11, 2019

www.medtronic.com/productperformance 651050