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

Device Survival Probability

4598_SURV
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    1 yr                  
% Survival 98.8                  
#   156                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 472
Cumulative Months of Follow-Up 3818
Number of Leads Active in Study 421
Information 3

Qualifying Complications

Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 2
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

US Acute Lead Observations

Cardiac Perforation 3
Conductor Fracture 1
Extra Cardiac Stimulation 27
Failure to Capture 9
Impedance Out of Range 4
Lead Dislodgement 21
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants14460
Estimated Active USA Implants13919
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution33634
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 2
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 February 3, 2017

www.medtronic.com/productperformance 476050