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

Device Survival Probability

4396_SURV
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    1 yr 2 yr 3 yr 4 yr            
% Survival 99.7 99.4 98.3 98.3            
#   331 226 143 65            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 429
Cumulative Months of Follow-Up 12052
Number of Leads Active in Study 234
Information 4

Qualifying Complications

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

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 14
Failure to Capture 7
Lead Dislodgement 33
Information

Distribution Data

US Market Release2011-03-31
CE Approval Date2009-12-18
Registered USA Implants7150
Estimated Active USA Implants5890
US Market Release2011-03-31
CE Approval Date2009-12-18
Estimated WW Distribution24590
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 0
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 5
Insulation Breach 0
Crimp/Weld/Bond 0
Other 1
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 February 3, 2017

www.medtronic.com/productperformance 476050