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

Device Survival Probability

4598_SURV
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    1 yr at 18.0 mo                
% Survival 98.8 98.8                
#   256 137                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 607
Cumulative Months of Follow-Up 6520
Number of Leads Active in Study 521
Information 5

Qualifying Complications

Failure to Sense 1
Lead Dislodgement 4
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 4
Conductor Fracture 1
Extra Cardiac Stimulation 37
Failure to Capture 17
Impedance Out of Range 4
Lead Dislodgement 25
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants20883
Estimated Active USA Implants20025
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution46328
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 0
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 3
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Canted
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Quad Pole
More
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 July 31, 2017

www.medtronic.com/productperformance 501050