4296 Attain Ability Plus
Left-Heart Pacing
4296 Attain Ability Plus
ALL
Information

Device Survival Probability

4296_SURV
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    1 yr 2 yr at 30.0 mo              
% Survival 99.4 98.4 98.4              
#   709 232 88              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1347
Cumulative Months of Follow-Up 18385
Number of Leads Active in Study 971
Information 10

Qualifying Complications

Extra Cardiac Stimulation 3
Failure to Capture 2
Impedance Out of Range 0
Lead Dislodgement 5
Other 0
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Extra Cardiac Stimulation 42
Failure to Capture 18
Impedance Out of Range 8
Insulation Breach 4
Lead Dislodgement 93
Information

Distribution Data

US Market Release2011-04-01
CE Approval Date2009-12-18
Registered USA Implants28068
Estimated Active USA Implants25563
US Market Release2011-04-01
CE Approval Date2009-12-18
Estimated WW Distribution57437
Information

USA Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 2
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 6
Insulation Breach 0
Crimp/Weld/Bond 2
Other 3
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Distal Double Curve
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Dual Electrodes
More
Serial Number Prefix RRA
Lead Body Diameter 5.3 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 9, 2015

www.medtronic.com/productperformance 351052