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 5 yr 6 yr 7 yr      
% Survival 99.7 99.5 99.2 99.2 98.9 98.9 98.9      
#   1499 1143 836 542 281 129 54      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2031
Cumulative Months of Follow-Up 64512
Number of Leads Active in Study 1179
Information 13

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 4
Impedance Out of Range 1
Lead Dislodgement 7
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 8
Conductor Fracture 1
Extra Cardiac Stimulation 105
Failure to Capture 76
Impedance Out of Range 12
Lead Dislodgement 41
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants39620
Estimated Active USA Implants31643
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution78199
Information

USA Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 7
Information

WW Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 10
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 Quadripolar
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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 December 1, 2023

www.medtronic.com/productperformance 951051