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

Device Survival Probability

4598_SURV
Loading...











    1 yr 2 yr                
% Survival 98.9 98.9                
#   344 111                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 723
Cumulative Months of Follow-Up 9097
Number of Leads Active in Study 609
Information 6

Qualifying Complications

Failure to Sense 1
Lead Dislodgement 5
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 45
Failure to Capture 23
Impedance Out of Range 5
Lead Dislodgement 27
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants25448
Estimated Active USA Implants24395
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution54491
Information

USA Returned Product Analysis

Conductor Fracture 3
Insulation Breach 1
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 7
Insulation Breach 1
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
Hide this content

Data as of January 31, 2018

www.medtronic.com/productperformance 601051