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 3 yr 4 yr            
% Survival 98.8 98.0 97.6 96.4            
#   1075 719 350 79            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1410
Cumulative Months of Follow-Up 34500
Number of Leads Active in Study 800
Information 25

Qualifying Complications

Extra Cardiac Stimulation 7
Failure to Capture 6
Lead Dislodgement 11
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Extra Cardiac Stimulation 53
Failure to Capture 20
Impedance Out of Range 8
Insulation Breach 4
Lead Dislodgement 109
Information

Distribution Data

US Market Release2011-04-01
CE Approval Date2009-12-18
Registered USA Implants31867
Estimated Active USA Implants27077
US Market Release2011-04-01
CE Approval Date2009-12-18
Estimated WW Distribution92299
Information

USA Returned Product Analysis

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

WW Returned Product Analysis

Conductor Fracture 7
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 August 3, 2016

www.medtronic.com/productperformance 451050