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

Device Survival Probability

4798MRI_SURV
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    1 yr 2 yr at 30.0 mo              
% Survival 100.0 100.0 100.0              
#   176 96 69              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 482
Cumulative Months of Follow-Up 5472
Number of Leads Active in Study 412
Information

Qualifying Complications

Failure to Capture 0
Impedance Out of Range 0
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 4
Conductor Fracture 1
Extra Cardiac Stimulation 44
Failure to Capture 32
Impedance Out of Range 15
Lead Dislodgement 62
Oversensing 1
Information

Distribution Data

US Market Release2017-04-17
CE Approval Date
Registered USA Implants20441
Estimated Active USA Implants19255
US Market Release2017-04-17
CE Approval Date
Estimated WW Distribution58798
Information

USA Returned Product Analysis

Conductor Fracture 0
Insulation Breach 0
Crimp/Weld/Bond 0
Other 4
Information

WW Returned Product Analysis

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

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation
Lead Function
Lead Placement
Lead Tip Location
Pace/Sense Polarity
More
Serial Number Prefix QFX
Lead Body Diameter
Insulation
Pace/Sense Connector Style
High Voltage Connector
Steroid
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Data as of December 16, 2021

www.medtronic.com/productperformance 851050