4398 Attain Performa Straight
Left-Heart Pacing
4398 Attain Performa Straight
ALL
Information

Device Survival Probability

4398_SURV
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    1 yr 2 yr 3 yr 4 yr            
% Survival 99.7 99.7 98.7 98.7            
#   636 313 152 57            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1230
Cumulative Months of Follow-Up 19960
Number of Leads Active in Study 966
Information 7

Qualifying Complications

Failure to Capture 3
Impedance Out of Range 1
Lead Dislodgement 3
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 6
Extra Cardiac Stimulation 73
Failure to Capture 37
Impedance Out of Range 5
Lead Dislodgement 29
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants24926
Estimated Active USA Implants23328
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution49071
Information

USA Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 4
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Bipolar
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Serial Number Prefix QUB
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 10, 2020

www.medtronic.com/productperformance 751050