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            
#   1016 588 176 58            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1579
Cumulative Months of Follow-Up 29856
Number of Leads Active in Study 1204
Information 14

Qualifying Complications

Extra Cardiac Stimulation 3
Lead Dislodgement 11
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 133
Failure to Capture 73
Impedance Out of Range 17
Lead Dislodgement 109
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants59871
Estimated Active USA Implants56403
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution117646
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 1
Crimp/Weld/Bond 0
Other 15
Information

WW Returned Product Analysis

Conductor Fracture 3
Insulation Breach 1
Crimp/Weld/Bond 0
Other 18
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 12, 2018

www.medtronic.com/productperformance 626050