4396 Attain Ability Straight
Left-Heart Pacing
4396 Attain Ability Straight
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Information

Device Survival Probability

4396_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr        
% Survival 99.8 99.5 98.4 98.4 98.4 98.4        
#   366 288 246 194 130 65        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 465
Cumulative Months of Follow-Up 18414
Number of Leads Active in Study 186
Information 7

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 3
Impedance Out of Range 0
Insulation (not further defined) 1
Lead Dislodgement 2
Other 0
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 2
Extra Cardiac Stimulation 19
Failure to Capture 10
Lead Dislodgement 34
Information

Distribution Data

US Market Release2011-03-31
CE Approval Date2009-12-18
Registered USA Implants7989
Estimated Active USA Implants6251
US Market Release2011-03-31
CE Approval Date2009-12-18
Estimated WW Distribution28916
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 0
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 6
Insulation Breach 0
Crimp/Weld/Bond 0
Other 0
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 Dual Electrodes
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Serial Number Prefix RAE
Lead Body Diameter 4.0 FR
Insulation Polyurethane (outer) Silicone (inner)
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of November 8, 2019

www.medtronic.com/productperformance 726050