4298 Attain Performa
Left-Heart Pacing
4298 Attain Performa
ALL
Information

Device Survival Probability

4298_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 102.0 mo  
% Survival 99.2 98.7 98.6 98.6 98.4 98.2 98.2 98.2 98.2  
#   1882 1595 1363 1120 804 589 378 176 85  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2262
Cumulative Months of Follow-Up 107609
Number of Leads Active in Study 850
Information 28

Qualifying Complications

Extra Cardiac Stimulation 5
Failure to Capture 5
Impedance Out of Range 0
Lead Dislodgement 15
Other 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 7
Conductor Fracture 1
Extra Cardiac Stimulation 233
Failure to Capture 168
Failure to Sense 1
Impedance Out of Range 44
Lead Dislodgement 256
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants118671
Estimated Active USA Implants91583
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution254689
Information

USA Returned Product Analysis

Conductor Fracture 7
Insulation Breach 0
Crimp/Weld/Bond 0
Other 27
Information

WW Returned Product Analysis

Conductor Fracture 10
Insulation Breach 0
Crimp/Weld/Bond 0
Other 31
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Double Curve
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Quadripolar
More
Serial Number Prefix QUA
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) Silicone (inner)
Pace/Sense Connector Style IS-4
High Voltage Connector n/a
Steroid Yes
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Data as of April 30, 2024

www.medtronic.com/productperformance 1001052