4598 Attain Performa S
Left-Heart Pacing
4598 Attain Performa S
ALL
Information

Device Survival Probability

4598_SURV
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    1 yr 2 yr 3 yr at 42.0 mo            
% Survival 99.2 99.0 99.0 99.0            
#   684 404 184 99            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1174
Cumulative Months of Follow-Up 21840
Number of Leads Active in Study 902
Information 8

Qualifying Complications

Extra Cardiac Stimulation 2
Failure to Capture 0
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 5
Other 0
Information

US Acute Lead Observations

Cardiac Perforation 8
Conductor Fracture 1
Extra Cardiac Stimulation 69
Failure to Capture 37
Impedance Out of Range 13
Lead Dislodgement 42
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants41957
Estimated Active USA Implants39704
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution85535
Information

USA Returned Product Analysis

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

WW Returned Product Analysis

Conductor Fracture 9
Insulation Breach 0
Crimp/Weld/Bond 0
Other 8
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation S-shape
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Quad Pole
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Serial Number Prefix QUC
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) SI-polyimide (SI-PI)(inner)
Pace/Sense Connector Style IS4-LLLL
High Voltage Connector n/a
Steroid Yes
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Data as of November 8, 2019

www.medtronic.com/productperformance 726050