4398 Attain Performa Straight
Left-Heart Pacing
4398 Attain Performa Straight
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Information

Device Survival Probability

4398_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr  
% Survival 99.7 99.6 99.3 99.1 98.9 98.9 98.6 98.6 98.6  
#   1802 1514 1216 927 689 462 267 120 52  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2140
Cumulative Months of Follow-Up 96602
Number of Leads Active in Study 873
Information 18

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 7
Impedance Out of Range 1
Insulation (not further defined) 1
Lead Dislodgement 8
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 8
Conductor Fracture 2
Extra Cardiac Stimulation 119
Failure to Capture 97
Impedance Out of Range 20
Lead Dislodgement 48
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants46387
Estimated Active USA Implants36644
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution93150
Information

USA Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 12
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Quadripolar
More
Serial Number Prefix QUB
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) SI-polyimide (SI-PI)(inner)
Pace/Sense Connector Style IS-4
High Voltage Connector n/a
Steroid Yes
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Data as of June 8, 2026

www.medtronic.com/productperformance 22521