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 4 yr 5 yr          
% Survival 99.3 99.0 98.9 98.9 98.9          
#   1603 1105 775 460 159          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2110
Cumulative Months of Follow-Up 61103
Number of Leads Active in Study 1336
Information 17

Qualifying Complications

Extra Cardiac Stimulation 4
Failure to Capture 0
Impedance Out of Range 0
Lead Dislodgement 12
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 6
Conductor Fracture 1
Extra Cardiac Stimulation 188
Failure to Capture 103
Failure to Sense 1
Impedance Out of Range 28
Lead Dislodgement 181
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants86244
Estimated Active USA Implants78936
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution168629
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 0
Crimp/Weld/Bond 0
Other 18
Information

WW Returned Product Analysis

Conductor Fracture 7
Insulation Breach 0
Crimp/Weld/Bond 0
Other 21
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 29, 2020

www.medtronic.com/productperformance 776050