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        
% Survival 98.6 97.9 97.6 97.1 96.4 96.4        
#   1130 902 721 507 283 63        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1445
Cumulative Months of Follow-Up 51205
Number of Leads Active in Study 551
Information 34

Qualifying Complications

Extra Cardiac Stimulation 12
Failure to Capture 8
Lead Dislodgement 13
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 1
Extra Cardiac Stimulation 59
Failure to Capture 29
Impedance Out of Range 9
Insulation Breach 4
Lead Dislodgement 115
Information

Distribution Data

US Market Release2011-04-01
CE Approval Date2009-12-18
Registered USA Implants34419
Estimated Active USA Implants28200
US Market Release2011-04-01
CE Approval Date2009-12-18
Estimated WW Distribution104733
Information

USA Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 2
Other 5
Information

WW Returned Product Analysis

Conductor Fracture 7
Insulation Breach 0
Crimp/Weld/Bond 2
Other 5
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 12, 2018

www.medtronic.com/productperformance 626050