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

Device Survival Probability

4398_SURV
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    1 yr at 18.0 mo                
% Survival 99.6 99.6                
#   151 80                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 400
Cumulative Months of Follow-Up 4051
Number of Leads Active in Study 348
Information 1

Qualifying Complications

Lead Dislodgement 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Extra Cardiac Stimulation 37
Failure to Capture 20
Impedance Out of Range 2
Lead Dislodgement 8
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants10553
Estimated Active USA Implants10056
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution24261
Information

USA Returned Product Analysis

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

WW Returned Product Analysis

Conductor Fracture 0
Insulation Breach 0
Crimp/Weld/Bond 0
Other 5
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 July 31, 2017

www.medtronic.com/productperformance 501050