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

Device Survival Probability

4598_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr at 66.0 mo        
% Survival 99.2 98.8 98.8 98.6 98.2 98.2        
#   1063 814 503 299 148 73        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1286
Cumulative Months of Follow-Up 41359
Number of Leads Active in Study 727
Information 15

Qualifying Complications

Extra Cardiac Stimulation 3
Failure to Capture 0
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 11
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 105
Failure to Capture 65
Impedance Out of Range 21
Lead Dislodgement 66
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants59127
Estimated Active USA Implants47461
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution122195
Information

USA Returned Product Analysis

Conductor Fracture 6
Insulation Breach 0
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 11
Insulation Breach 0
Crimp/Weld/Bond 0
Other 13
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
Hide this content

Data as of December 16, 2021

www.medtronic.com/productperformance 851050