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

Device Survival Probability

4298_SURV
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    1 yr 2 yr                
% Survival 99.0 98.4                
#   446 59                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1133
Cumulative Months of Follow-Up 11455
Number of Leads Active in Study 969
Information 9

Qualifying Complications

Extra Cardiac Stimulation 1
Impedance Out of Range 0
Lead Dislodgement 8
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 1
Extra Cardiac Stimulation 82
Failure to Capture 46
Impedance Out of Range 12
Lead Dislodgement 64
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants35222
Estimated Active USA Implants33478
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution71764
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 0
Crimp/Weld/Bond 0
Other 11
Information

WW Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 13
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 February 3, 2017

www.medtronic.com/productperformance 476050