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 5 yr 6 yr 7 yr 8 yr    
% Survival 98.7 97.9 97.7 97.2 96.7 96.5 96.5 96.5    
#   1154 926 759 631 527 422 258 86    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1462
Cumulative Months of Follow-Up 65314
Number of Leads Active in Study 397
Information 35

Qualifying Complications

Extra Cardiac Stimulation 12
Failure to Capture 9
Impedance Out of Range 0
Lead Dislodgement 13
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 1
Extra Cardiac Stimulation 61
Failure to Capture 32
Impedance Out of Range 11
Insulation Breach 4
Lead Dislodgement 118
Information

Distribution Data

US Market Release2011-04-01
CE Approval Date2009-12-18
Registered USA Implants34931
Estimated Active USA Implants17833
US Market Release2011-04-01
CE Approval Date2009-12-18
Estimated WW Distribution115319
Information

USA Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 2
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 10
Insulation Breach 0
Crimp/Weld/Bond 2
Other 4
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation 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 October 11, 2021

www.medtronic.com/productperformance 826050