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

Device Survival Probability

4398_SURV
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    1 yr 2 yr 3 yr 4 yr at 54.0 mo          
% Survival 99.7 99.7 99.0 99.0 97.7          
#   802 447 210 102 58          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1377
Cumulative Months of Follow-Up 25935
Number of Leads Active in Study 1040
Information 8

Qualifying Complications

Failure to Capture 3
Impedance Out of Range 1
Lead Dislodgement 4
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 6
Extra Cardiac Stimulation 80
Failure to Capture 43
Impedance Out of Range 6
Lead Dislodgement 34
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants27306
Estimated Active USA Implants25351
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution52755
Information

USA Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 5
Information

WW Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 7
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 Bipolar
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Serial Number Prefix QUB
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