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              
% Survival 99.2 98.9 98.5              
#   855 371 58              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1435
Cumulative Months of Follow-Up 22963
Number of Leads Active in Study 1143
Information 12

Qualifying Complications

Extra Cardiac Stimulation 2
Lead Dislodgement 10
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 3
Conductor Fracture 1
Extra Cardiac Stimulation 120
Failure to Capture 64
Impedance Out of Range 16
Lead Dislodgement 98
Information

Distribution Data

US Market Release2014-08-01
CE Approval Date2013-01-01
Registered USA Implants52266
Estimated Active USA Implants49297
US Market Release2014-08-01
CE Approval Date2013-01-01
Estimated WW Distribution103460
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 1
Crimp/Weld/Bond 0
Other 14
Information

WW Returned Product Analysis

Conductor Fracture 3
Insulation Breach 1
Crimp/Weld/Bond 0
Other 16
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 Bipolar
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 January 31, 2018

www.medtronic.com/productperformance 601051