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 at 42.0 mo            
% Survival 99.8 99.8 99.1 99.1            
#   504 234 102 60            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1105
Cumulative Months of Follow-Up 15459
Number of Leads Active in Study 890
Information 4

Qualifying Complications

Failure to Capture 2
Impedance Out of Range 0
Lead Dislodgement 2
Other 0
Information

US Acute Lead Observations

Cardiac Perforation 4
Extra Cardiac Stimulation 63
Failure to Capture 35
Impedance Out of Range 5
Lead Dislodgement 23
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants22779
Estimated Active USA Implants21522
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution45577
Information

USA Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 4
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 November 8, 2019

www.medtronic.com/productperformance 726050