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

Device Survival Probability


4296_SURV
    1 yr at 18 mo                
% Survival 99.2 99.2                
#   342 131                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1080
Cumulative Months of Follow-Up 9104
Number of Leads Active in Study 865
Information 5

Qualifying Complications

Extra Cardiac Stimulation 2
Failure to Capture 1
Lead Dislodgement 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Extra Cardiac Stimulation 21
Failure to Capture 10
Impedance Out of Range 3
Insulation Breach 2
Lead Dislodgement 63
Information

Distribution Data

US Market Release2011-04-01
CE Approval Date2009-12-18
Registered USA Implants20387
Estimated Active USA Implants18968
US Market Release2011-04-01
CE Approval Date2009-12-18
Estimated WW Distribution43602
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 0
Crimp/Weld/Bond 1
Other 2
Information

WW Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 1
Other 2
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 January 31, 2014

www.medtronic.com/productperformance 301050