4196 Attain Ability
Left-Heart Pacing
4196 Attain Ability
ALL
Information

Device Survival Probability

4196_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr          
% Survival 97.9 97.2 96.8 96.3 95.8          
#   1676 1245 889 452 97          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2122
Cumulative Months of Follow-Up 64953
Number of Leads Active in Study 874
Information 60

Qualifying Complications

Conductor Fracture 2
Extra Cardiac Stimulation 13
Failure to Capture 18
Impedance Out of Range 1
Insulation (not further defined) 1
Lead Dislodgement 22
Other 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 2
Extra Cardiac Stimulation 81
Failure to Capture 50
Failure to Sense 1
Impedance Out of Range 7
Insulation Breach 2
Lead Dislodgement 183
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants63800
Estimated Active USA Implants46755
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution162635
Information

USA Returned Product Analysis

Conductor Fracture 17
Insulation Breach 0
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 25
Insulation Breach 1
Crimp/Weld/Bond 0
Other 16
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 Bipolar
More
Serial Number Prefix PVI
Lead Body Diameter 4.0 FR
Insulation Polyurethane (outer); SI-polyimide (inner)
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of November 2, 2015

www.medtronic.com/productperformance 376051