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 4 yr at 54.0 mo          
% Survival 99.3 98.9 98.9 98.5 98.5          
#   936 586 353 168 91          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1247
Cumulative Months of Follow-Up 31812
Number of Leads Active in Study 825
Information 12

Qualifying Complications

Extra Cardiac Stimulation 2
Failure to Capture 0
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 9
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 9
Conductor Fracture 1
Extra Cardiac Stimulation 83
Failure to Capture 46
Impedance Out of Range 16
Lead Dislodgement 51
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants49758
Estimated Active USA Implants46375
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution99676
Information

USA Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 7
Information

WW Returned Product Analysis

Conductor Fracture 9
Insulation Breach 0
Crimp/Weld/Bond 0
Other 12
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
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 October 29, 2020

www.medtronic.com/productperformance 776050