4798 Attain Stability Quad
Left-Heart Pacing
4798 Attain Stability Quad
ALL
Information

Device Survival Probability

4798_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 66.0 mo        
% Survival 99.8 99.5 99.5 99.1 99.1 99.1        
#   912 481 266 128 66 54        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1482
Cumulative Months of Follow-Up 29681
Number of Leads Active in Study 993
Information 8

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 2
Failure to Capture 3
Lead Dislodgement 2
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 9
Conductor Fracture 2
Extra Cardiac Stimulation 104
Failure to Capture 125
Impedance Out of Range 42
Lead Dislodgement 113
Oversensing 1
Information

Distribution Data

US Market Release2019-06-03
CE Approval Date2017-04-24
Registered USA Implants56731
Estimated Active USA Implants52807
US Market Release2019-06-03
CE Approval Date2017-04-24
Estimated WW Distribution147821
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 0
Crimp/Weld/Bond 0
Other 15
Information

WW Returned Product Analysis

Conductor Fracture 1
Insulation Breach 0
Crimp/Weld/Bond 0
Other 21
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Non-electrically Active Side Fixation
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Quadripolar
More
Serial Number Prefix QFX
Lead Body Diameter 4.4 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 November 20, 2024

www.medtronic.com/productperformance 1026050