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 at 30.0 mo              
% Survival 99.8 99.8 99.8              
#   259 126 68              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 713
Cumulative Months of Follow-Up 8258
Number of Leads Active in Study 604
Information 2

Qualifying Complications

Failure to Capture 1
Lead Dislodgement 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 3
Extra Cardiac Stimulation 46
Failure to Capture 24
Impedance Out of Range 4
Lead Dislodgement 12
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants15912
Estimated Active USA Implants15158
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution33672
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 0
Crimp/Weld/Bond 0
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 1
Insulation Breach 0
Crimp/Weld/Bond 0
Other 6
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 October 12, 2018

www.medtronic.com/productperformance 626050