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

Device Survival Probability

4298_SURV
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    1 yr 2 yr at 30.0 mo              
% Survival 99.1 98.7 97.9              
#   680 201 64              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1328
Cumulative Months of Follow-Up 17330
Number of Leads Active in Study 1102
Information 11

Qualifying Complications

Extra Cardiac Stimulation 1
Lead Dislodgement 10
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 1
Extra Cardiac Stimulation 109
Failure to Capture 54
Impedance Out of Range 15
Lead Dislodgement 82
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants45572
Estimated Active USA Implants43001
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution91285
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 1
Crimp/Weld/Bond 0
Other 13
Information

WW Returned Product Analysis

Conductor Fracture 3
Insulation Breach 1
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 July 31, 2017

www.medtronic.com/productperformance 501050